Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
510(k) Number |
K172634 |
Device Name |
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components |
Applicant |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Shahrir Alam |
Correspondent |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
325 Corporate Dr. |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Shahrir Alam |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/01/2017 |
Decision Date | 11/16/2017 |
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
|
|
|