510(k) K090375 ยท OLO Orthopedic Stereotaxic Instrument
ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
| Applicant | Aesculap Implant System, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, Jun 23, 2009 |
| Received | Feb 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090375
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.