510(k) K080547 ยท HAW Neurological Stereotaxic Instrument
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106
| Applicant | Aesculap Implant System, Inc., Center Valley PA, US |
| Decision | Substantially Equivalent, May 23, 2008 |
| Received | Feb 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080547
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.