| Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
| 510(K) Number |
K102688 |
| Device Name |
MERETE LOCKING BONE PLATE SYSTEM II |
| Applicant |
| MERETE MEDICAL GMBH |
| 49 purchase street |
|
rye,
NY
10580
|
|
| Contact |
emmanuel anapliotis |
| Regulation Number | 888.3030
|
| Classification Product Code |
|
| Date Received | 09/17/2010 |
| Decision Date | 12/03/2010 |
| 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
|
|
|