510(k) K240137 ยท GXR Cover, Burr Hole
Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
| Applicant | Neos Surgery S.L, Cerdanyola, ES |
| Decision | Substantially Equivalent, Feb 16, 2024 |
| Received | Jan 18, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K240137
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.