TPLC - Total Product Life Cycle

• Device: intervertebral fusion device with bone graft, lumbar
• Definition: Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
• Product Code: MAX
• Regulation Number: 888.3080
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
4-WEB SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
4-WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB, INC.
	SUBSTANTIALLY EQUIVALENT	5
4WEB,INC.
	SUBSTANTIALLY EQUIVALENT	1
ACCEL SPINE
	SUBSTANTIALLY EQUIVALENT	2
ACUITY SURGICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADCURA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED MEDICAL TECHNOLOGIES AG
	SUBSTANTIALLY EQUIVALENT	5
ADVANCED MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED RESEARCH MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED VERTEBRAL SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
AEGIS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP IMPLANT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ALLIANCE PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	2
ALLIANCE PARTNERS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	16
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	5
AMEDICA CORP
	SUBSTANTIALLY EQUIVALENT	1
AMEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	4
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	4
AMPLIFY SURGICAL INC
	SUBSTANTIALLY EQUIVALENT	1
AMPLIFY SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
ATLAS SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
ATLAS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
AURORA SPINE
	SUBSTANTIALLY EQUIVALENT	1
BAAT MEDICAL PRODUCTS BV
	SUBSTANTIALLY EQUIVALENT	1
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENVENUE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
BIEDERMANN MOTECH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
BINDER BIOMEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOGEND THERAPEUTICS CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOGENNIX, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOMET SPINE
	SUBSTANTIALLY EQUIVALENT	1
BIOMET SPINE (AKA EBI, LLC)
	SUBSTANTIALLY EQUIVALENT	2
BIOMET SPINE LLC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET SPINE, LLC.
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUESTONE SYNERGY
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	5
CAMBER SPINE TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	5
CENTINEL SPINE
	SUBSTANTIALLY EQUIVALENT	1
CENTINEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP
	SUBSTANTIALLY EQUIVALENT	3
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE SAS
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	2
COALIGN INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	9
COGENT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	3
COLIGNE, AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	3
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	6
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
DEPUY SPINE
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIFUSION TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
DOUBLE MEDICAL TECHNOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
EBI, L.P.
	SUBSTANTIALLY EQUIVALENT	3
EISERTECH, LLC
	SUBSTANTIALLY EQUIVALENT	2
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	5
ELITE SURGICAL SUPPLIES (PTY) LTD.
	SUBSTANTIALLY EQUIVALENT	1
EMINENT SPINE
	SUBSTANTIALLY EQUIVALENT	1
EMINENT SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	4
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	3
EXPANDING INNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	3
EXPANDING INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
EXPANDING ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
FACETLINK DBA LINKSPINE
	SUBSTANTIALLY EQUIVALENT	1
FIMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FLOSPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	8
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	13
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HD LIFESCIENCES LLC
	SUBSTANTIALLY EQUIVALENT	1
HT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
INFRONT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
INNOVA SPINAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	7
INNOVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
INNVOTEC SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA SPINE (INTEGRA LIFESCIENCES)
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC
	SUBSTANTIALLY EQUIVALENT	3
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	4
INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
INTERVENTIONAL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	4
JOHNSON AND JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	2
K2M
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	11
K7 LLC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
KEOS
	SUBSTANTIALLY EQUIVALENT	3
KUROS BIOSCIENCES BV
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
L & K BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
L&K BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
LANX, INC.
	SUBSTANTIALLY EQUIVALENT	2
LDR SPINE USA
	SUBSTANTIALLY EQUIVALENT	3
LEGEND SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	5
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	11
LIFE SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	8
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DESIGNS, LLC
	SUBSTANTIALLY EQUIVALENT	3
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	6
MEDICREA TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
MEDITECH ADVISORS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDITECH SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	3
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	8
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	9
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	6
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	19
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	6
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDYSSEY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	7
MET 1 TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MET ONE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MET ONE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	3
NANOHIVE MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	3
NEO MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
NEOORTHO PRODUTOS ORTOPEDICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
NEUROPRO SPINAL JAXX, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	3
NEXT ORTHOSURGICAL
	SUBSTANTIALLY EQUIVALENT	1
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	4
NGMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
NLT SPINE LTD
	SUBSTANTIALLY EQUIVALENT	5
NUVASIVE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	4
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	32
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
OC MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
OMNI SURGICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
OMNIA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
ORBBO SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	6
ORTHOFIX US LLC
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED LP
	SUBSTANTIALLY EQUIVALENT	1
OUROBOROS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
OUROBOROS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PANTHEON SPINAL
	SUBSTANTIALLY EQUIVALENT	3
PAONAN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PARADIGM SPINE, GMBH
	SUBSTANTIALLY EQUIVALENT	1
PINNACLE SPINE GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	8
PIONEER SURGICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRECIFIT MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	2
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PRINTERPREZZ
	SUBSTANTIALLY EQUIVALENT	1
PRISM SURGICAL DESIGNS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
QUALGENIX LLC
	SUBSTANTIALLY EQUIVALENT	1
R TREE INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	1
RAED M. ALI, M.D., INC.
	SUBSTANTIALLY EQUIVALENT	1
RAED M. ALI, MD., INC.
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS LLC
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	3
RENOVIS SURGICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
REPUBLIC SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	2
ROYAL OAK MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RTI SURGICAL, INC. DBA RTI BIOLOGICS
	SUBSTANTIALLY EQUIVALENT	1
RUBICON SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	3
SAPPHIRE MEDICAL GROUP, INC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	17
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	2
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	4
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	4
SINTEA PLUSTEK
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN MEDICAL (PTY) LTD
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL EDGE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC.
	SUBSTANTIALLY EQUIVALENT	4
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	6
SPINAL STABILITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL USA
	SUBSTANTIALLY EQUIVALENT	1
SPINE INNOVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE SMITH PARTNERS L.P.
	SUBSTANTIALLY EQUIVALENT	2
SPINE VIEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	12
SPINEART
	SUBSTANTIALLY EQUIVALENT	10
SPINEEX INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINEEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	5
SPINEMED GES.M.B.H
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	10
SPINEOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	11
SPINEVISION S.A.
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION SAS
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, SAS
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY
	SUBSTANTIALLY EQUIVALENT	1
SPINEWORKS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINEWORXX AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	5
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	4
SUMMIT SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH INC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
TDM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
THOMPSON MIS INC
	SUBSTANTIALLY EQUIVALENT	1
TIDES MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TITAN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	6
TRANS1
	SUBSTANTIALLY EQUIVALENT	1
TRANS1 INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
TRANS1, INC.
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
ULRICH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
VALLUM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VERTEBRAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	6
VERTERA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WENZEL SPINE
	SUBSTANTIALLY EQUIVALENT	1
WENZEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
X-SPINE SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
XENCO MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	4
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	5
ZAVATION, LLC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER BIOMET SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER TRABECULAR METAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZS FAB INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	362	362
2015	524	524
2016	647	647
2017	595	595
2018	615	615
2019	699	699
2020	640	640
2021	621	621
2022	617	622
2023	578	578
2024	277	277

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1855	1855
Adverse Event Without Identified Device or Use Problem	810	810
Migration	558	558
Fracture	501	505
Migration or Expulsion of Device	428	428
Device-Device Incompatibility	311	311
Mechanical Problem	215	215
Material Integrity Problem	160	160
Device Operates Differently Than Expected	148	148
Compatibility Problem	134	134
Mechanical Jam	131	131
Collapse	127	127
Insufficient Information	115	115
Device Dislodged or Dislocated	113	113
Material Deformation	112	113
Malposition of Device	86	86
Appropriate Term/Code Not Available	81	81
Material Fragmentation	76	76
Detachment of Device or Device Component	75	75
Unintended Movement	72	72
Crack	66	66
Fitting Problem	57	57
Difficult to Insert	54	55
Loose or Intermittent Connection	53	53
Mechanics Altered	52	52
Patient Device Interaction Problem	46	46
Material Twisted/Bent	44	44
Positioning Problem	44	44
Use of Device Problem	43	43
Detachment Of Device Component	43	43
Difficult to Remove	41	41
Improper or Incorrect Procedure or Method	39	39
No Apparent Adverse Event	34	34
Activation Failure	30	30
Device Slipped	29	29
Bent	25	25
Physical Resistance/Sticking	25	25
Loosening of Implant Not Related to Bone-Ingrowth	21	21
Separation Failure	19	19
Device Handling Problem	18	18
Material Separation	17	17
Inadequacy of Device Shape and/or Size	17	17
Leak/Splash	17	17
Contamination /Decontamination Problem	16	16
Difficult To Position	14	14
Sticking	14	14
Material Disintegration	14	14
Entrapment of Device	13	13
Patient-Device Incompatibility	13	13
Material Protrusion/Extrusion	13	13
Device Damaged by Another Device	12	12
Disassembly	12	12
Device Sensing Problem	11	11
Expulsion	11	11
Failure to Align	10	10
Failure To Adhere Or Bond	10	10
Disconnection	9	9
Device Markings/Labelling Problem	8	8
Biocompatibility	8	8
Connection Problem	8	8
Difficult to Advance	8	8
Pressure Problem	7	7
Failure to Advance	7	7
Split	7	7
Device Issue	7	7
Difficult or Delayed Positioning	7	7
Positioning Failure	7	7
Nonstandard Device	7	7
Off-Label Use	7	7
Noise, Audible	7	7
Material Split, Cut or Torn	6	6
Failure to Eject	6	6
Inaccurate Information	6	6
Metal Shedding Debris	6	6
Imprecision	6	6
Defective Device	6	6
Activation, Positioning or Separation Problem	6	6
Osseointegration Problem	6	6
No Pressure	5	5
Naturally Worn	5	5
Device Operational Issue	5	5
Fluid/Blood Leak	5	5
Component Falling	5	5
Failure to Osseointegrate	5	5
Unstable	5	5
Product Quality Problem	5	5
Unintended System Motion	4	4
Component Missing	4	4
Device Damaged Prior to Use	4	4
Material Erosion	4	4
Cut In Material	4	4
Dull, Blunt	4	4
Installation-Related Problem	4	4
Human Factors Issue	4	4
Human-Device Interface Problem	4	4
Packaging Problem	4	4
Device Difficult to Maintain	4	4
Output Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Loss of Osseointegration	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	1750	1750
No Clinical Signs, Symptoms or Conditions	1321	1326
Pain	554	555
No Code Available	553	553
No Consequences Or Impact To Patient	463	463
Failure of Implant	247	247
Insufficient Information	226	226
Injury	182	182
Device Embedded In Tissue or Plaque	170	170
Unspecified Infection	149	149
No Information	143	143
No Patient Involvement	122	122
Foreign Body In Patient	121	121
Nerve Damage	81	81
Non-union Bone Fracture	76	76
Hematoma	68	68
Post Operative Wound Infection	65	65
Bone Fracture(s)	62	62
Unspecified Tissue Injury	60	60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	57	57
Osteolysis	52	52
Neuropathy	43	43
Numbness	39	40
Joint Laxity	35	35
Hemorrhage/Bleeding	29	29
Neurological Deficit/Dysfunction	28	28
Cerebrospinal Fluid Leakage	26	26
Spinal Column Injury	25	25
Patient Problem/Medical Problem	25	25
Impaired Healing	24	24
Weakness	23	23
Stenosis	23	23
Laceration(s)	23	23
Blood Loss	22	22
Tissue Damage	20	20
Sedation	19	19
Damage to Ligament(s)	19	19
Paralysis	18	18
Spinal Cord Injury	18	18
Perforation of Vessels	18	18
Discomfort	18	18
Fall	17	17
Unspecified Nervous System Problem	17	17
Bacterial Infection	16	16
Wound Dehiscence	15	15
Not Applicable	15	15
Dysphagia/ Odynophagia	14	14
Hypersensitivity/Allergic reaction	14	14
Inadequate Pain Relief	13	14
Vertebral Fracture	13	13
Unspecified Musculoskeletal problem	12	12
Reaction	12	12
Death	12	12
Arthritis	12	12
Muscle Weakness	11	11
Inadequate Osseointegration	11	11
Swelling	11	11
Ambulation Difficulties	10	11
Cyst(s)	10	10
Fever	10	10
Neck Pain	9	9
Sepsis	8	8
Excessive Tear Production	8	8
Inflammation	8	8
Headache	8	8
Bowel Perforation	8	8
Incontinence	7	7
Aspiration/Inhalation	7	7
Tingling	7	7
Hypoesthesia	6	6
Hernia	6	6
Disability	6	6
Paraplegia	6	6
Pulmonary Embolism	6	6
Abdominal Pain	6	6
Perforation	6	6
Undesired Nerve Stimulation	6	6
Loss of Range of Motion	6	6
Rash	6	6
Decreased Sensitivity	6	6
Intervertebral Disc Compression or Protrusion	6	6
Implant Pain	6	6
Speech Disorder	5	5
Paresis	5	5
Abscess	5	5
Cardiac Arrest	5	5
Depression	5	5
Rupture	5	5
Seroma	5	5
Pneumonia	4	4
Urinary Tract Infection	4	4
Joint Disorder	4	4
Osteopenia/ Osteoporosis	4	4
Anemia	4	4
Itching Sensation	4	4
Muscle Spasm(s)	4	4
Low Blood Pressure/ Hypotension	4	4
Thrombosis/Thrombus	4	4
Disc Impingement	4	4
Nervous System Injury	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	4-Web Inc.	II	Dec-16-2014
2	Aesculap, Inc.	II	Jul-25-2013
3	Alphatec Spine, Inc.	II	May-29-2012
4	Alphatec Spine, Inc.	II	Nov-12-2009
5	Amendia, Inc	II	Dec-20-2016
6	Biomet Spine LLC.	II	Dec-16-2014
7	Biomet Spine, LLC	II	Feb-09-2015
8	CTL Medical Corporation	II	Jul-04-2020
9	Captiva Spine, Inc	II	Jun-07-2012
10	CoreLink LLC	II	Jan-12-2023
11	DePuy Orthopaedics, Inc.	II	Mar-02-2018
12	DePuy Spine, Inc.	II	Jul-01-2022
13	DePuy Spine, Inc.	II	Apr-27-2019
14	Ebi, Llc	II	Sep-27-2013
15	Genesys Orthopedic Systems, LLC	II	Jun-01-2012
16	Globus Medical, Inc.	II	Aug-22-2020
17	Howmedica Osteonics Corp.	II	Dec-13-2018
18	Howmedica Osteonics Corp.	II	Sep-12-2016
19	Integrity Implants Inc.	II	Nov-07-2018
20	Interventional Spine Inc	II	Jan-03-2017
21	K2M, Inc	II	Jun-01-2021
22	Kiscomedica S.A.	II	Feb-27-2017
23	Medacta Usa	II	Nov-18-2014
24	Medicrea International	II	Aug-24-2023
25	Medicrea International	II	Feb-12-2020
26	Medtronic Sofamor Danek USA Inc	II	Jul-24-2009
27	Medtronic Sofamor Danek USA, Inc	II	Apr-20-2021
28	Neuropro Spinal Jaxx	II	Apr-10-2018
29	Orthofix, Inc.	II	Feb-15-2012
30	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Jun-26-2015
31	SPINEART SA	III	Nov-22-2019
32	Spinal Elements	II	May-23-2018
33	Spinal Elements, Inc	II	Jan-05-2015
34	Spinal Solutions, LLC	II	May-27-2013
35	Spinal Solutions, LLC	II	Apr-22-2013
36	Spine Smith Holdings, LLC	II	Sep-19-2013
37	Spine Smith Partners LP	II	Mar-10-2013
38	Spine Wave, Inc.	II	Sep-11-2013
39	SpineFrontier, Inc.	II	May-07-2014
40	SpineFrontier, Inc.	II	Nov-21-2012
41	Stryker Spine	II	Apr-20-2021
42	Stryker Spine	II	Oct-10-2018
43	Stryker Spine	II	Feb-23-2016
44	Synthes (USA) Products LLC	II	Apr-14-2016
45	Synthes Spine	II	Jan-30-2009
46	Synthes USA (HQ), Inc.	II	Nov-04-2011
47	X Spine Systems Inc	II	Oct-18-2016
48	XTANT MEDICAL INC	II	Jan-30-2019
49	Zimmer Biomet Spine, Inc	II	Mar-28-2017
50	Zimmer Biomet Spine, Inc	II	Aug-11-2016
51	Zimmer Trabecular Metal Technology, Inc.	III	May-10-2017
52	Zimmer, Inc.	II	Jan-09-2013
53	Zimmer, Inc.	I	Dec-22-2012