| Device Classification Name |
appliance, fixation, spinal intervertebral body
|
| 510(K) Number |
K122733 |
| Model |
07.01657.XXX, 07.01658.XXX, 07.01659.XXX, 07.01660.001, 07.01661.001
|
| Device Name |
V2F ANTERIOR FIXATION SYSTEM |
| Applicant |
| ZIMMER SPINE, INC |
| 5301 riata park court |
| building f |
|
austin,
TX
78727
|
|
| Contact |
jennifer tribbett |
| Regulation Number | 888.3060
|
| Classification Product Code |
|
| Date Received | 09/11/2012 |
| Decision Date | 12/07/2012 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Orthopedic
|
| Review Advisory Committee |
Orthopedic
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|