Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K190402 |
Device Name |
Triathlon Total Knee System-Additional Components |
Applicant |
Stryker Orthopaedics (aka Howmedica Osteonics Corp.) |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Margaret Crowe Klippel |
Correspondent |
Stryker Orthopaedics (aka Howmedica Osteonics Corp.) |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Margaret Crowe Klippel |
Regulation Number | 888.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/19/2019 |
Decision Date | 08/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|