510(k) K210912 ยท OWB Interventional Fluoroscopic X-Ray System
Excelsius3D
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Aug 12, 2021 |
| Received | Mar 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210912
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.