coflex® Interlaminar Technology
FDA premarket approval P110008/S008 · decided 2018-04-25
Approval details
- PMA number
- P110008
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- 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
- 2017-06-26
- Decision date
- 2018-04-25
- Days to decision
- 303 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- Approval for introducing a set of disposable instruments for the coflex® and for Otto Klumpp to manufacture these disposable instruments at Burgstraße 18, 72336, Balingen-Ostdorf, 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 |