510(k) K251971 ยท OLO Orthopedic Stereotaxic Instrument
RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
| Applicant | Stryker Instruments, Portage MI, US |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Jun 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251971
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.