The following data is part of a premarket notification filed by Howmedica Osteonics Corp Aka Stryker Orthopaedics with the FDA for Triathlon Pkr X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts.
| Device ID | K180612 |
| 510k Number | K180612 |
| Device Name: | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430 |
| Contact | Emily Dimambro |
| Correspondent | Emily Dimambro Howmedica Osteonics Corp Aka Stryker Orthopaedics 325 Corporate Dr. Mahwah, NJ 07430 |
| Product Code | HSX |
| Subsequent Product Code | HRY |
| Subsequent Product Code | NPJ |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-08 |
| Decision Date | 2018-06-07 |
| Summary: | summary |