510(k) K211616 ยท OLO Orthopedic Stereotaxic Instrument
ExcelsiusHub
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Aug 25, 2021 |
| Received | May 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Globus Medical, Inc. ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.