510(k) K031337 ยท HAW Neurological Stereotaxic Instrument
ACUMEN SURGICAL NAVIGATION SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 15, 2003 |
| Received | Apr 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031337
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.