510(k) K090615 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
| Applicant | Arthrocare Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 3, 2009 |
| Received | Mar 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090615
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | ArthroCare Corporation ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.