Device Classification Name |
Prosthesis, Chin, Internal
|
510(k) Number |
K121315 |
Device Name |
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT |
Applicant |
HOWMEDICA OSTEONICS CORP. |
15 Dart Rd |
NEWNAN,
GA
30265
|
|
Applicant Contact |
STEPHANIE FULLARD |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
15 Dart Rd |
NEWNAN,
GA
30265
|
|
Correspondent Contact |
STEPHANIE FULLARD |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 05/02/2012 |
Decision Date | 11/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|