Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K053514 |
Device Name |
TRIATHLON TOTAL KNEE SYSTEM |
Applicant |
STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
TIFFANI ROGERS |
Correspondent |
STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
TIFFANI ROGERS |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 12/16/2005 |
Decision Date | 01/26/2006 |
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
|
|
|