SECURE-C CERVICAL ARTIFICIAL DISC
FDA premarket approval P100003/S007 · decided 2017-08-18
Approval details
- PMA number
- P100003
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SECURE-C CERVICAL ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Globus Medical, Inc.
- Date received
- 2016-12-30
- Decision date
- 2017-08-18
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Audubon, PA
- Statement
- Approval for updated labeling to reflect seven (7) year data.
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|---|---|---|
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| 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 |