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.
| Device Type ID | 4672 |
| Device Name | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Physical State | Hollow Cylinder Or Rectangular Box Made Of Metal Or Polymer With Integrated Fixation. |
| Technical Method | Acts As A Disc Spacer And Holds Bone Graft; Also Includes Some Form Of Integrated Fixation To Maintain Stability By Direct Purchase Into The Bony Vertebral Endplates. |
| Target Area | Intervertebral Disc Space |
| Regulation Description | Intervertebral Body Fusion Device. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3080 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4672 |
| Device | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Product Code | OVE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intervertebral Body Fusion Device. |
| CFR Regulation Number | 888.3080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMENDIA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CENTINEL SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CHOICE SPINE, LP | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CTL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENESYS SPINE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROSTRUCTURES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEXUS SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PROVIDENCE MEDICAL TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENOVIS SURGICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAFE ORTHOPAEDICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINAL ELEMENTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINAL ELEMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINE WAVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEFRONTIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPINEFRONTIER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPINESMITH HOLDINGS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TITAN SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
XENCO MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZAVATION, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 126 |
Adverse Event Without Identified Device Or Use Problem | 63 |
Detachment Of Device Or Device Component | 27 |
Device Operates Differently Than Expected | 21 |
Fracture | 20 |
Mechanical Problem | 20 |
Migration Or Expulsion Of Device | 19 |
Material Twisted / Bent | 18 |
Unintended Movement | 17 |
Detachment Of Device Component | 15 |
Screw | 14 |
Material Fragmentation | 10 |
Fitting Problem | 7 |
Difficult To Insert | 7 |
Difficult To Advance | 7 |
Material Integrity Problem | 7 |
Crack | 6 |
Dull, Blunt | 5 |
Material Separation | 5 |
Ring | 5 |
Migration | 5 |
Device Dislodged Or Dislocated | 4 |
Mechanical Jam | 4 |
Device-Device Incompatibility | 4 |
Loose Or Intermittent Connection | 4 |
Malposition Of Device | 3 |
Insufficient Information | 3 |
Material Deformation | 3 |
No Apparent Adverse Event | 3 |
Disassembly | 3 |
Failure To Adhere Or Bond | 3 |
Use Of Device Problem | 2 |
Component Missing | 2 |
Tip | 2 |
Peeled / Delaminated | 2 |
Partial Blockage | 2 |
Complete Blockage | 2 |
Human Factors Issue | 2 |
Device Damaged Prior To Use | 2 |
Entrapment Of Device | 2 |
Material Erosion | 1 |
Scratched Material | 1 |
Disconnection | 1 |
Naturally Worn | 1 |
Packaging Problem | 1 |
Device Slipped | 1 |
Failure To Align | 1 |
Plate | 1 |
Positioning Failure | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Component Or Accessory Incompatibility | 1 |
Device Damaged By Another Device | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Sticking | 1 |
Inappropriate Tactile Prompt / Feedback | 1 |
Appropriate Term/Code Not Available | 1 |
Incorrect Measurement | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Patient-Device Incompatibility | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 497 |
| 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 | TITAN SPINE, LLC | II | Aug-03-2015 |
| 6 | TITAN SPINE, LLC | II | Mar-26-2015 |