coflex® Interlaminar Technology
FDA premarket approval P110008/S006 · decided 2016-11-30
Approval details
- PMA number
- P110008
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- coflex® Interlaminar Technology
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Companion Spine France
- Date received
- 2016-09-01
- Decision date
- 2016-11-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- Approval for a change to the coflex® labeling to indicate a 5-year shelf-life for coflex® devices manufactured by the second source manufacturer, Orchid.
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| Record | Firm | Date |
|---|---|---|
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |