Paradigm Spine Coflex Interlaminar Stabilization Device
FDA premarket approval P110008/S009 · decided 2018-06-21
Approval details
- PMA number
- P110008
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Paradigm Spine Coflex Interlaminar Stabilization Device
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Companion Spine France
- Date received
- 2017-07-03
- Decision date
- 2018-06-21
- Days to decision
- 353 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |