SECURE®-C Cervical Artificial Disc
FDA premarket approval P100003/S008 · decided 2023-06-12
Approval details
- PMA number
- P100003
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SECURE®-C Cervical Artificial Disc
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Globus Medical, Inc.
- Date received
- 2023-02-07
- Decision date
- 2023-06-12
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Audubon, PA
- Statement
- Approval to update labeling for the SECURE®-C to reflect the findings of the Enhanced Surveillance Study (PAS2).
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510(k) clearances by this applicant
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|---|---|---|
| TRIVANCE™ Hip Stem (K254043) | Globus Medical, Inc. | 2026-08-04 |
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| SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (K253739) | Globus Medical, Inc. | 2026-05-07 |
| SCRIPT™ Implant System (K253401) | Globus Medical, Inc. | 2026-04-29 |
| AUTOBAHN™ Nailing System (K261043) | Globus Medical, Inc. | 2026-04-24 |
| RIB LINK™ Fixation System (K252166) | Globus Medical, Inc. | 2026-02-26 |
| HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876) | Globus Medical, Inc. | 2025-12-22 |
| ExcelsiusGPS™ Instruments (K250599) | Globus Medical, Inc. | 2025-11-05 |