PMA
P970010: NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
FDA PMA · Filler, bone void, non-osteoinduction · Synthes (Usa)
Key facts
| PMA number | P970010 |
|---|---|
| Trade name | NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT |
| Generic name | Filler, bone void, non-osteoinduction |
| Applicant | Synthes (Usa) |
| Owner/operator | SYNTHES (USA) Products LLC / Medical Device Business Service |
| Product code | MBS |
| Approval date | Dec 23, 1998 |
| Docket number | 99M-4361 |
| Notice date | Oct 20, 1999 |
| Establishment registration | 3008812560 |
| FEI number | 3008812560 |
At a glance
- 1–9 Supplements
- Aug 31, 2000 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: