Device Classification Name |
Prosthesis, Chin, Internal
|
510(k) Number |
K153508 |
Device Name |
Stryker CMF MEDPOR Customized Implant |
Applicant |
Stryker |
750 Trade Centre Way, Suite 200 |
Portage,
MI
49002
|
|
Applicant Contact |
Jonathan Schell |
Correspondent |
Stryker |
750 Trade Centre Way, Suite 200 |
Portage,
MI
49002
|
|
Correspondent Contact |
Jonathan Schell |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 12/07/2015 |
Decision Date | 02/05/2016 |
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
|