Coflex Interlaminar Technology
PMA P110008
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP110008 | Date17 Oct 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Prosthesis, spinous process spacer/plate
- PMA Number
- FDA Product Code
- NQO
- Device Class
- Class III
- Advisory Committee
- Orthopedic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
Coflex Interlaminar Technology is a prosthesis classified as a spinous process spacer/plate. It is indicated for use in one- or two-level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate functional impairment who experience relief in flexion from leg/buttock/groin pain, with or without back pain, and who have undergone at least 6 months of non-operative treatment.
The device is intended to be implanted midline between adjacent lamina of one or two contiguous lumbar motion segments following decompression of stenosis. It is supplied as an implantable device requiring surgical placement and is authorized under FDA PMA P110008. Sterility, reusability, MRI safety, sizes, and storage conditions are not specified in the provided data.
Other devices from Companion Spine France
Questions
AI-generated answers, 18 Sep 2026
What is the Coflex Interlaminar Technology used for?
The Coflex Interlaminar Technology is indicated for use in one- or two-level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate functional impairment who experience relief in flexion from leg, buttock, or groin pain, with or without back pain, and who have undergone at least six months of non-operative treatment. It is implanted midline between adjacent lamina after decompression of the affected level(s).
Who manufactures the Coflex Interlaminar Technology?
The Coflex Interlaminar Technology is manufactured by Companion Spine France, located in Merignac Gironde, France, as stated in the applicant and address fields of the device data.
What regulatory authorization does the Coflex Interlaminar Technology have?
The Coflex Interlaminar Technology has FDA PMA (Premarket Approval) authorization, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the PMA number P110008 in the specifications.