ExcelsiusGPS Cranial 1.0 Module
FDA 510(k) clearance K200047 · decided 2020-07-10
Clearance details
- K-number
- K200047
- Device name
- ExcelsiusGPS Cranial 1.0 Module
- Applicant
- Globus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-09
- Decision date
- 2020-07-10
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- OLO
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Audubon, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and recall (Z-0995-2024) | Globus Medical, Inc. | 2024-02-06 |
| Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and recall (Z-0996-2024) | Globus Medical, Inc. | 2024-02-06 |
| Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement recall (Z-0997-2024) | Globus Medical, Inc. | 2024-02-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006) | Globus Medical, Inc. | 2016-05-17 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005) | Globus Medical, Inc. | 2014-12-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004) | Globus Medical, Inc. | 2014-06-30 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003) | Globus Medical, Inc. | 2014-05-08 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002) | Globus Medical, Inc. | 2013-09-06 |
| SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001) | Globus Medical, Inc. | 2013-03-15 |