The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-apatite.
| Device ID | K200782 |
| 510k Number | K200782 |
| Device Name: | Triathlon Posterior Stabilized Femoral Component - Beaded With Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - Beaded With Peri-Apatite |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Nora O'connor |
| Correspondent | Nora O'connor Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-26 |
| Decision Date | 2020-05-13 |