510(k) K200047 ยท OLO Orthopedic Stereotaxic Instrument
ExcelsiusGPS Cranial 1.0 Module
| Applicant | Globus Medical, Inc., Audubon PA, US |
| Decision | Substantially Equivalent, Jul 10, 2020 |
| Received | Jan 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200047
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref : 6143.1834S Open, Classified |
HAW | None listed |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref: 6143.1842S Open, Classified |
HAW | None listed |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref: 6143.1870S Open, Classified |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.