Definition: Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
| Device Type ID | 4658 |
| Device Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Physical State | Hollow Cylinder Or Rectangular Box Made Of Metal Or Polymer. |
| Technical Method | Acts As A Disc Spacer And Holds Bone Graft. |
| 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 | ODP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4658 |
| Device | Intervertebral Fusion Device With Bone Graft, Cervical |
| Product Code | ODP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intervertebral Body Fusion Device. |
| CFR Regulation Number | 888.3080 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
4WEB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACKERMANN INSTRUMENTE GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALLIANCE PARTNERS LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALPHATEC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALPHATEC HOLDINGS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMEDICA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ASTURA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ATLAS SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BK MEDITECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAMBER SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAMBER SPINE/MEDICAL TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CAPTIVA SPINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CORELINK LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CTL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CUTTING EDGE SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEGEN MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVOLUTION SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GENESYS SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
GS MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HT MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICOTEC AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
K2M | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KALITEC MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
L&K BIOMED CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
L&K BIOMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDITECH SPINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC SOFAMOR DANEK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MEDYSSEY USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MET 1 TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOVIS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROSTRUCTURES, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEXT ORTHOSURGICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEXXT SPINE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
NVISION BIOMEDICAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ORTHOFIX INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOFIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSEUS FUSION SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PINNACLE SPINE GROUP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIONEER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PIONEER SURGICAL TECHNOLOGY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POROSTEON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECIFIT MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RELIANCE MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
RHAUSLER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RTI SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SHANGHAI SANYOU MEDICAL CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SILONY MEDICAL GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOLCO BIOMEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPINEFRONTIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPINEFRONTIER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SPINEWAY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SURGICAL INSTRUMENT MANUFACTURERS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE ORTHOPEDIC IMPLANT COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TITAN SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TYBER MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TYBER MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U&I CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
U&I MEDICAL DEVICES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
XENCO MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 61 |
Break | 27 |
Malposition Of Device | 15 |
Positioning Problem | 13 |
Migration Or Expulsion Of Device | 13 |
Fracture | 12 |
Patient-Device Incompatibility | 5 |
Mechanical Problem | 4 |
Unintended Movement | 3 |
Device Issue | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Appropriate Term/Code Not Available | 3 |
Use Of Device Problem | 2 |
Migration | 2 |
Device Operates Differently Than Expected | 2 |
Bent | 1 |
Difficult To Remove | 1 |
Physical Resistance | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Device Damaged By Another Device | 1 |
Material Deformation | 1 |
Failure To Align | 1 |
Detachment Of Device Or Device Component | 1 |
Crack | 1 |
Spacer | 1 |
Biocompatibility | 1 |
| Total Device Problems | 182 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | RTI Surgical, Inc. | II | Jan-03-2014 |