510(k) K101235 ยท GXR Cover, Burr Hole
CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
| Applicant | Neos Surgery S.L, Alexandria VA, US |
| Decision | Substantially Equivalent, Oct 25, 2010 |
| Received | May 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101235
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.