The following data is part of a premarket notification filed by Stryker Orthopaedics (aka Howmedica Osteonics Corp.) with the FDA for Triathlon Total Knee System-additional Components.
| Device ID | K190402 |
| 510k Number | K190402 |
| Device Name: | Triathlon Total Knee System-Additional Components |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Stryker Orthopaedics (aka Howmedica Osteonics Corp.) 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Margaret Crowe Klippel |
| Correspondent | Margaret Crowe Klippel Stryker Orthopaedics (aka Howmedica Osteonics Corp.) 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-08-22 |