COFLEX® INTERLAMINAR TECHNOLOGY
FDA premarket approval P110008 · decided 2012-10-17
Approval details
- PMA number
- P110008
- Trade name
- COFLEX® INTERLAMINAR TECHNOLOGY
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Companion Spine France
- Date received
- 2011-03-03
- Decision date
- 2012-10-17
- Days to decision
- 594 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac Gironde
- Statement
- APPROVAL FOR THE COFLEX INTERLAMINAR TECHNOLOGY. THIS DEVICE IS INDICATED FOR USE IN ONE- OR TWO-LEVEL LUMBAR STENOSIS FROM L1- L5 IN SKELETALLY MATURE PATIENTS WITH AT LEAST MODERATE IMPAIRMENT IN FUNCTION, WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCKS/ GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND WHO HAVE UNDERGONE AT LEAST 6 MONTH OF NON-OPERATIVE TREATMENT. THE COFLEX IS INTENDED TO BE IMPLANTED MIDLINE BETWEEN ADJACENT LAMINA OF 1 OR 2 CONTIGUOUS LUMBAR MOTION SEGMENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Companion Spine DIAM™ Instrumentation (K253118) | Companion Spine France | 2025-12-16 |