SECURE -C CERVICAL ARTIFICIAL DISC
FDA premarket approval P100003/S003 · decided 2014-05-08
Approval details
- PMA number
- P100003
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SECURE -C CERVICAL ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Globus Medical, Inc.
- Date received
- 2013-06-21
- Decision date
- 2014-05-08
- Days to decision
- 321 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Audubon, PA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TRIVANCE™ Hip Stem (K254043) | Globus Medical, Inc. | 2026-08-04 |
| ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251) | Globus Medical, Inc. | 2026-07-31 |
| 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 |