510(k) K090313 ยท OLO Orthopedic Stereotaxic Instrument
PIGALILEO TKR BASE V2.3 AND CAS V4.1
| Applicant | Smith & Nephew, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Mar 11, 2009 |
| Received | Feb 9, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090313
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.