Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K132624 |
Device Name |
TRIATHLON TRITANIUM METAL-BACKED PATELLA |
Applicant |
STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
SHIKHA KHANDELWAL |
Correspondent |
STRYKER ORTHOPAEDICS |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
SHIKHA KHANDELWAL |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/22/2013 |
Decision Date | 11/26/2013 |
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
|
|
|