COFLEX INTERLAMINAR TECHNOLOGY
FDA premarket approval P110008/S007 · decided 2017-03-10
Approval details
- PMA number
- P110008
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- COFLEX INTERLAMINAR TECHNOLOGY
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Companion Spine France
- Date received
- 2016-10-18
- Decision date
- 2017-03-10
- Days to decision
- 143 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- Approval of changes to the protocol for the post-approval study (PAS) 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 |
|---|---|---|
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |