COFLEX® INTERLAMINAR TECHNOLOGY
FDA premarket approval P110008/S010 · decided 2018-04-20
Approval details
- PMA number
- P110008
- Supplement
- S010
- 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
- 2017-08-17
- Decision date
- 2018-04-20
- Days to decision
- 246 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- Approval for a manufacturing site located at Diener Implants GmbH, Rudolf-Diesel-Strasse: 18, Tuttllingen, Germany.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |