510(k) K143393 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Triathlon Tritanium Cone Augments
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 13, 2015 |
| Received | Nov 26, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S
Product Usage:
Is a reusable instrument that is part of the Triathlon Primary total Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.