PMA
P060023: BRYAN CERVICAL DISC PROSTHESIS
FDA PMA · Prosthesis, intervertebral disc · Companion Spine France Sas
Key facts
| PMA number | P060023 |
|---|---|
| Trade name | BRYAN CERVICAL DISC PROSTHESIS |
| Generic name | Prosthesis, intervertebral disc |
| Applicant | Companion Spine France Sas |
| Owner/operator | Companion Spine |
| Product code | MJO |
| Approval date | May 12, 2009 |
| Docket number | 09M-0243 |
| Notice date | May 27, 2009 |
| Establishment registration | 3025435185 |
| FEI number | 3025435185 |
At a glance
- 1–9 Supplements
- Mar 18, 2020 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- No Withdrawn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: