| Device Classification Name |
plate, fixation, bone
|
|---|
| 510(K) Number |
K110476 |
|---|
| Model |
437110S, 437112S, 437114S, 437116S, 437118S, 437120S, 437130S, 437132S, 437134S, 437136S, 437138S, 437140S
|
| Device Name |
AXSOS (TM) LOCKING PLATE SYSTEM |
|---|
| Applicant |
| STRYKER CORP. |
| 325 corporate drive |
|
mahwah,
NJ
07430
|
|
| Contact |
estela celi |
| Regulation Number | 888.3030
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/18/2011 |
|---|
| Decision Date | 03/18/2011 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
