PMA
P110008: COFLEX® INTERLAMINAR TECHNOLOGY
FDA PMA · Prosthesis, spinous process spacer/plate · Companion Spine France
Key facts
| PMA number | P110008 |
|---|---|
| Trade name | COFLEX® INTERLAMINAR TECHNOLOGY |
| Generic name | Prosthesis, spinous process spacer/plate |
| Applicant | Companion Spine France |
| Owner/operator | Companion Spine |
| Product code | NQO |
| Approval date | Oct 17, 2012 |
| Docket number | 12M-1085 |
| Notice date | Nov 8, 2012 |
| Establishment registration | 3005426761 |
| FEI number | 3005426761 |
At a glance
- 10–99 Supplements
- May 22, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: