510(k) K180817 · PEK Spinous Process Plate
AERIAL Interspinous Fixation
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, May 21, 2018 |
| Received | Mar 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180817
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.