510(k) K171651 ยท OLO Orthopedic Stereotaxic Instrument
EXCELSIUS GPS
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Aug 16, 2017 |
| Received | Jun 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2024 | Globus Medical, Inc. ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.