Device Classification Name |
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
|
510(k) Number |
K230416 |
Device Name |
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® |
Applicant |
Stryker |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Allison Byrne |
Correspondent |
Stryker |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Allison Byrne |
Regulation Number | 888.3510
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/16/2023 |
Decision Date | 05/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|