510(k) K042986 ยท GXR Cover, Burr Hole
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Nov 17, 2004 |
| Received | Oct 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042986
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.