Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device intervertebral fusion device with integrated fixation, cervical
Definition Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Product CodeOVE
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESPOKE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET SPINE
  SUBSTANTIALLY EQUIVALENT 2
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CENTINEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 2
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SA
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
EBI, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDISONINNO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELEVATION SPINE
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 5
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
INCITE INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
INCITE INNOVATION LLC
  SUBSTANTIALLY EQUIVALENT 2
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LANX, INC
  SUBSTANTIALLY EQUIVALENT 1
LDR SPINE USA
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S. A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY,INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RHAUSLER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
SEASPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL USA
  SUBSTANTIALLY EQUIVALENT 1
SPINE SMITH PARTNERS L.P.
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINESMITH HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEUP INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES SPINE CO.LP
  SUBSTANTIALLY EQUIVALENT 3
THEKEN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 150 150
2015 173 173
2016 145 145
2017 134 134
2018 210 210
2019 169 169
2020 162 162
2021 192 192
2022 200 200
2023 150 150
2024 96 96

Device Problems MDRs with this Device Problem Events in those MDRs
Break 467 467
Adverse Event Without Identified Device or Use Problem 258 258
Fracture 144 144
Material Integrity Problem 111 111
Detachment of Device or Device Component 78 78
Mechanical Problem 71 71
Material Twisted/Bent 60 60
Difficult to Insert 60 60
Migration 56 56
Crack 54 54
Migration or Expulsion of Device 50 50
Device Operates Differently Than Expected 47 47
Insufficient Information 43 43
Patient Device Interaction Problem 39 39
Compatibility Problem 38 38
Device Slipped 37 37
Detachment Of Device Component 32 32
Device Dislodged or Dislocated 28 28
Material Fragmentation 28 28
Unintended Movement 27 27
Physical Resistance/Sticking 24 24
Positioning Problem 23 23
Bent 20 20
Malposition of Device 20 20
Improper or Incorrect Procedure or Method 20 20
Device-Device Incompatibility 19 19
Material Separation 18 18
Loose or Intermittent Connection 17 17
Fitting Problem 16 16
Material Deformation 15 15
Component Missing 14 14
Failure To Adhere Or Bond 14 14
Mechanical Jam 14 14
Difficult to Remove 13 13
Appropriate Term/Code Not Available 12 12
Activation, Positioning or Separation Problem 12 12
Use of Device Problem 11 11
Failure to Osseointegrate 11 11
Difficult to Advance 10 10
No Apparent Adverse Event 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Loss of Osseointegration 8 8
Failure to Advance 8 8
Entrapment of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Component Falling 6 6
Peeled/Delaminated 6 6
Unstable 5 5
Positioning Failure 5 5
Dull, Blunt 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 517 517
No Clinical Signs, Symptoms or Conditions 391 391
No Consequences Or Impact To Patient 230 230
No Code Available 159 159
Failure of Implant 94 94
Pain 89 89
Dysphagia/ Odynophagia 74 74
Insufficient Information 54 54
No Information 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
No Patient Involvement 36 36
Neck Pain 31 31
Bone Fracture(s) 24 24
Sedation 22 22
Osteolysis 21 21
Non-union Bone Fracture 21 21
Foreign Body In Patient 20 20
Hematoma 19 19
Injury 17 17
Impaired Healing 17 17
Cerebrospinal Fluid Leakage 16 16
Nerve Damage 15 15
Unspecified Infection 13 13
Paralysis 12 12
Foreign Body Sensation in Eye 12 12
Patient Problem/Medical Problem 11 11
Device Embedded In Tissue or Plaque 10 10
Physical Asymmetry 9 9
Ossification 9 9
Unspecified Tissue Injury 8 8
Malunion of Bone 8 8
Swollen Glands 8 8
Post Operative Wound Infection 8 8
Quadriplegia 8 8
Stenosis 6 6
Neurological Deficit/Dysfunction 6 6
Discomfort 6 6
Dysphasia 6 6
Not Applicable 5 5
Airway Obstruction 5 5
Spinal Cord Injury 5 5
Burning Sensation 5 5
Swelling/ Edema 4 4
Subluxation 4 4
Swollen Lymph Nodes 4 4
Swelling 4 4
Loss of Range of Motion 4 4
Erosion 3 3
Numbness 3 3
Weakness 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Amendia, Inc II Jan-04-2018
2 Amendia, Inc II Jan-09-2017
3 Ebi, Llc II Dec-24-2014
4 Exactech, Inc. II Feb-13-2016
5 K2M, Inc II Oct-13-2021
6 Medtronic Sofamor Danek USA Inc II Oct-12-2021
7 SpineFrontier, Inc. II Jul-12-2019
8 Synthes USA HQ, Inc. II Dec-05-2013
9 TITAN SPINE, LLC II Aug-03-2015
10 TITAN SPINE, LLC II Mar-26-2015
11 U&I CORP. II Apr-29-2020
-
-