510(k) K010361 ยท GXR Cover, Burr Hole
MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
| Applicant | Medtronic PS Medical, Goleta CA, US |
| Decision | Substantially Equivalent, May 7, 2001 |
| Received | Feb 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010361
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.