510(k) K230565 · OWI Bone Fixation Cerclage, Sublaminar
HILINE Fixation System
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Apr 20, 2023 |
| Received | Mar 1, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230565
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.