Device Classification Name |
material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
|
510(k) Number |
K103010 |
Device Name |
STRYKER PATIENT SPECIFIC POLYMER IMPLANT |
Applicant |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
STEPHANIE FITTS |
Correspondent |
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
STEPHANIE FITTS |
Regulation Number | 878.3500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/12/2010 |
Decision Date | 10/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|