PMA
P980048: BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
FDA PMA · Intervertebral fusion device with bone graft, lumbar · Sulzer Spine-Tech
Key facts
| PMA number | P980048 |
|---|---|
| Trade name | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Sulzer Spine-Tech |
| Owner/operator | Highridge Medical, LLC |
| Product code | MAX |
| Approval date | Apr 20, 2001 |
| Docket number | 03M-0122 |
| Notice date | Mar 31, 2003 |
| Establishment registration | 3012447612 |
| FEI number | 3012447612 |
At a glance
- 1–9 Supplements
- Oct 6, 2004 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: