| Device Classification Name |
Pin, Fixation, Smooth
|
| 510(k) Number |
K091955 |
| Device Name |
STRYKER SONICPIN SYSTEM |
| Applicant |
| Howmedica Osteonics Corp. |
| 325 Corporate Dr. |
|
Mahwah,
NJ
07430
|
|
| Applicant Contact |
AVITAL MERL-MARGULIES |
| Correspondent |
| Howmedica Osteonics Corp. |
| 325 Corporate Dr. |
|
Mahwah,
NJ
07430
|
|
| Correspondent Contact |
AVITAL MERL-MARGULIES |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 07/01/2009 |
| Decision Date | 04/02/2010 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|