510(k) K061362 ยท HAW Neurological Stereotaxic Instrument
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
| Applicant | Plus Orthopedics AG, Norfolk MA, US |
| Decision | Substantially Equivalent, Oct 6, 2006 |
| Received | May 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061362
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.