PMA supplement
P980048 S002: BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM
FDA PMA supplement · Normal 180 Day Track · Sulzer Spine-Tech
Key facts
| Original PMA | P980048 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM |
| Generic name | Intervertebral fusion device with bone graft, lumbar |
| Applicant | Sulzer Spine-Tech |
| Product code | MAX |
| Received date | Jun 22, 2001 |
| Decision date | Jun 19, 2002 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: