The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Triathlon Metal Backed Patella.
| Device ID | K061521 |
| 510k Number | K061521 |
| Device Name: | TRIATHLON METAL BACKED PATELLA |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-02 |
| Decision Date | 2006-08-11 |
| Summary: | summary |