The following data is part of a premarket notification filed by Stryker with the FDA for Triathlon Tritanium Tibial Baseplate.
| Device ID | K123486 |
| 510k Number | K123486 |
| Device Name: | TRIATHLON TRITANIUM TIBIAL BASEPLATE |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Stryker 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko Stryker 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 | 2012-11-13 |
| Decision Date | 2013-05-03 |
| Summary: | summary |