510(k) K071881 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
TRIATHLON PKR SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 9, 2007 |
| Received | Jul 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2009 | Stryker Howmedica Osteonics Corp. Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE
Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE
Intended Use:
- Moderately disabling joint disease of th Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.