The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Triathlon Tritanium Metal-backed Patella.
| Device ID | K132624 |
| 510k Number | K132624 |
| Device Name: | TRIATHLON TRITANIUM METAL-BACKED PATELLA |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Shikha Khandelwal |
| Correspondent | Shikha Khandelwal STRYKER ORTHOPAEDICS 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 | 2013-08-22 |
| Decision Date | 2013-11-26 |
| Summary: | summary |