COFLEX® INTERLAMINAR TECHNOLOGY
FDA premarket approval P110008/S005 · decided 2016-08-23
Approval details
- PMA number
- P110008
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COFLEX® INTERLAMINAR TECHNOLOGY
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Companion Spine France
- Date received
- 2016-03-09
- Decision date
- 2016-08-23
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- Approval for the manufacturing sites located at 6688 Dixie Highway, Bridgeport, MI 48722 for the packaging and labeling of the coflex Interlaminar Technology; 11911 Clark Street, Arcadia, CA 91006 for the laser marking, in-process cleaning, and inspection of the coflex Interlaminar Technology; and 1880 Industrial Drive, Libertyville, IL 60048 for the sterilization of the coflex Interlaminar Technology.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |