TPLC - Total Product Life Cycle

• Device: intervertebral fusion device with bone graft, lumbar
• Regulation Description: Intervertebral body fusion device.
• 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	6
ACCEL SPINE
	SUBSTANTIALLY EQUIVALENT	2
ACUITY SURGICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	3
ADCURA, INC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED MEDICAL TECHNOLOGIES AG
	SUBSTANTIALLY EQUIVALENT	5
ADVANCED RESEARCH MEDICAL, 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	3
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	2
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	17
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	5
AMEDICA CORP.
	SUBSTANTIALLY EQUIVALENT	4
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	4
AMPLIFY SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
ARTFX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
ATLAS SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
AURORA SPINE
	SUBSTANTIALLY EQUIVALENT	1
BAAT MEDICAL PRODUCTS B.V.
	SUBSTANTIALLY EQUIVALENT	1
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENVENUE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
BETHESDA MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
BIEDERMANN MOTECH GMBH & CO. KG
	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	3
BK MEDITECH, CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUESTONE SYNERGY
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	6
CAMBER SPINE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
CAPTIVA SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHPEDICS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED
	SUBSTANTIALLY EQUIVALENT	1
CARLSMED, INC.
	SUBSTANTIALLY EQUIVALENT	9
CENTINEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
CG MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CHOICESPINE, LP
	SUBSTANTIALLY EQUIVALENT	4
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	3
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	3
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	4
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
CUTTING EDGE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	6
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	5
DEGEN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIFUSION TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
DOUBLE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
EISERTECH, LLC
	SUBSTANTIALLY EQUIVALENT	2
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	5
ELITE SURGICAL SUPPLIES (PTY), LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELLIQUENCE, LLC
	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	7
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	7
GETSET SURGICAL, SA
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	17
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
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
IMPLANET
	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
INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA SPINE (INTEGRA LIFESCIENCES)
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC. DBA ACCELUS
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS, INC.
	SUBSTANTIALLY EQUIVALENT	7
INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
INTERVENTIONAL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	4
JOHNSON AND JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	2
K2M
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	10
K7, LLC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
KEOS
	SUBSTANTIALLY EQUIVALENT	3
KUROS BIOSCIENCES B.V
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	11
LANX, INC.
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA
	SUBSTANTIALLY EQUIVALENT	1
LEGEND SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	5
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	25
MEDACTA INERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	5
MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL DESIGNS, LLC
	SUBSTANTIALLY EQUIVALENT	2
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
	SUBSTANTIALLY EQUIVALENT	2
MEDICREA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	6
MEDITECH SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	11
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	6
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	29
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	6
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
MOBARN MEDICAL DEVICES, LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOHIVE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS, LLC
	SUBSTANTIALLY EQUIVALENT	4
NEO MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	2
NEOORTHO PRODUTOS ORTOPEDICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
NEUROPRO SPINALJAXX, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	3
NEXT ORTHOSURGICAL
	SUBSTANTIALLY EQUIVALENT	2
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
NEXXT SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
NGMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
NLT SPINE, LTD.
	SUBSTANTIALLY EQUIVALENT	5
NU VASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	34
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	4
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
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 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	7
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	2
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
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
RAED M. ALI, M.D., INC.
	SUBSTANTIALLY EQUIVALENT	2
RELIANCE MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	4
RENOVIS SURGICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D
	SUBSTANTIALLY EQUIVALENT	2
RETROPSOAS TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
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	19
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
SHANGHAI IATRICAL-TI TECHNOLOGIES CO , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI REACH MEDICAL INSTRUMENT CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI SANYOU MEDICAL CO, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	5
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	4
SINTEA PLUSTEK
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN MEDICAL (PTY) , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRUM SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	12
SPINAL STABILITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE INNOVATION, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINE VIEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	13
SPINEART
	SUBSTANTIALLY EQUIVALENT	8
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEEX, INC.
	SUBSTANTIALLY EQUIVALENT	3
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	3
SPINEMED GES.M.B.H
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	22
SPINEVISION S.A.
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, S.A.S.
	SUBSTANTIALLY EQUIVALENT	3
SPINEWAY
	SUBSTANTIALLY EQUIVALENT	1
SPINEWORKS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINEWORXX AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	2
SUMMIT SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES USA PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	2
TDM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
THOMPSON MIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TIDES MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TITAN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
TRANS1
	SUBSTANTIALLY EQUIVALENT	1
TRANS1 INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
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	3
VERTERA, INC.
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	4
WEIGAO ORTHOPAEDIC DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WENZEL SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
XENIX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	9
ZAVATION, LLC
	SUBSTANTIALLY EQUIVALENT	3
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZIMMER TRABECULAR METAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER TRABECULAR METAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZSFAB, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2016	647	647
2017	596	596
2018	616	616
2019	699	699
2020	640	640
2021	622	627
2022	618	630
2023	576	578
2024	729	731
2025	826	826
2026	105	105

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1712	1715
Adverse Event Without Identified Device or Use Problem	815	816
Migration	741	744
Fracture	603	612
Mechanical Problem	427	427
Device-Device Incompatibility	425	426
Migration or Expulsion of Device	349	349
Material Deformation	167	168
Material Integrity Problem	166	166
Collapse	158	158
Mechanical Jam	152	152
Compatibility Problem	137	137
Insufficient Information	133	135
Device Dislodged or Dislocated	110	110
Mechanics Altered	108	108
Device Operates Differently Than Expected	89	89
Appropriate Term/Code Not Available	89	89
Material Fragmentation	79	79
Detachment of Device or Device Component	78	78
Use of Device Problem	74	74
Malposition of Device	71	71
Material Twisted/Bent	64	64
Unintended Movement	64	64
Patient Device Interaction Problem	54	54
Fitting Problem	52	52
Crack	45	45
Difficult to Insert	43	44
Improper or Incorrect Procedure or Method	38	38
Loose or Intermittent Connection	35	35
No Apparent Adverse Event	33	33
Positioning Problem	31	31
Detachment Of Device Component	28	28
Physical Resistance/Sticking	27	27
Difficult to Remove	27	27
Loosening of Implant Not Related to Bone-Ingrowth	27	27
Device Slipped	26	26
Device Sensing Problem	21	21
Device Handling Problem	20	20
Activation Failure	18	18
Separation Failure	17	17
Entrapment of Device	17	17
Incorrect, Inadequate or Imprecise Result or Readings	16	16
Inadequacy of Device Shape and/or Size	15	15
Bent	15	15
Patient-Device Incompatibility	14	14
Naturally Worn	13	13
Failure to Align	13	13
Material Separation	12	12
Sticking	11	11
Material Disintegration	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2305	2319
No Known Impact Or Consequence To Patient	1322	1322
Pain	586	589
No Code Available	481	481
No Consequences Or Impact To Patient	367	367
Insufficient Information	305	312
Failure of Implant	271	271
Injury	165	165
Unspecified Infection	164	164
Device Embedded In Tissue or Plaque	139	139
Foreign Body In Patient	130	130
No Information	110	110
No Patient Involvement	97	97
Nerve Damage	89	90
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	82	82
Non-union Bone Fracture	80	80
Bone Fracture(s)	69	69
Unspecified Tissue Injury	67	68
Hematoma	65	65
Osteolysis	58	58
Neuropathy	54	54
Post Operative Wound Infection	54	54
Numbness	46	47
Joint Laxity	38	38
Hemorrhage/Bleeding	35	35
Cerebrospinal Fluid Leakage	34	34
Inadequate Osseointegration	34	34
Unspecified Nervous System Problem	30	30
Spinal Column Injury	27	27
Neurological Deficit/Dysfunction	25	25
Laceration(s)	25	25
Patient Problem/Medical Problem	24	24
Stenosis	22	22
Spinal Cord Injury	22	22
Perforation of Vessels	21	21
Ambulation Difficulties	21	22
Tissue Damage	19	19
Fall	19	19
Vertebral Fracture	19	19
Weakness	19	19
Paralysis	19	19
Blood Loss	19	19
Intervertebral Disc Compression or Protrusion	18	18
Discomfort	18	18
Damage to Ligament(s)	18	18
Unspecified Musculoskeletal problem	16	16
Wound Dehiscence	16	16
Dysphagia/ Odynophagia	15	15
Muscle Weakness	15	15
Not Applicable	14	14

Recalls
Manufacturer		Recall Class	Date Posted
1	4-Web Inc.	II	Dec-16-2014
2	Advanced Research Medical, LLC	II	Apr-29-2024
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11	CoreLink LLC	II	Jan-12-2023
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13	DePuy Spine, Inc.	II	Jul-01-2022
14	DePuy Spine, Inc.	II	Apr-27-2019
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17	Globus Medical, Inc.	II	Aug-22-2020
18	Howmedica Osteonics Corp.	II	Dec-13-2018
19	Howmedica Osteonics Corp.	II	Sep-12-2016
20	Innovasis, Inc	II	Sep-17-2024
21	Integrity Implants Inc.	II	Nov-07-2018
22	Interventional Spine Inc	II	Jan-03-2017
23	K2M, Inc	II	Jun-01-2021
24	Kiscomedica S.A.	II	Feb-27-2017
25	Medacta Usa	II	Nov-18-2014
26	Medicrea International	II	Jan-09-2026
27	Medicrea International	II	Aug-24-2023
28	Medicrea International	II	Feb-12-2020
29	Medtronic Sofamor Danek USA Inc	II	Nov-21-2025
30	Medtronic Sofamor Danek USA, Inc	II	Apr-20-2021
31	Neuropro Spinal Jaxx	II	Apr-10-2018
32	Orthofix U.S. LLC	III	Dec-11-2025
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34	Orthofix U.S. LLC	II	Mar-21-2025
35	Orthofix, Inc.	II	Feb-15-2012
36	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Jun-26-2015
37	SEASPINE ORTHOPEDICS CORPORATION	II	Sep-11-2025
38	SPINEART SA	III	Nov-22-2019
39	Spinal Elements	II	May-23-2018
40	Spinal Elements, Inc	II	Jan-05-2015
41	Spinal Solutions, LLC	II	May-27-2013
42	Spinal Solutions, LLC	II	Apr-22-2013
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44	Spine Smith Partners LP	II	Mar-10-2013
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51	Synthes (USA) Products LLC	II	Apr-14-2016
52	Synthes USA (HQ), Inc.	II	Nov-04-2011
53	X Spine Systems Inc	II	Oct-18-2016
54	XTANT MEDICAL INC	II	Jan-30-2019
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56	Zimmer Biomet Spine, Inc	II	Aug-11-2016
57	Zimmer Trabecular Metal Technology, Inc.	III	May-10-2017
58	Zimmer, Inc.	II	Jan-09-2013
59	Zimmer, Inc.	I	Dec-22-2012