Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
510(k) Number |
K122053 |
Device Name |
SHAPEMATCH CUTTING GUIDE |
Applicant |
STRYKER CORP. |
1600 HARBOR BAY DRIVE |
SUITE 200 |
ALAMEDA,
CA
94502
|
|
Applicant Contact |
TAMMY WHARTON |
Correspondent |
STRYKER CORP. |
1600 HARBOR BAY DRIVE |
SUITE 200 |
ALAMEDA,
CA
94502
|
|
Correspondent Contact |
TAMMY WHARTON |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/13/2012 |
Decision Date | 10/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|