510(k) K101448 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
OPUS SPEEDSCREW SYSTEM
| Applicant | Arthrocare Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 21, 2010 |
| Received | May 24, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor
Intended to be used for fixation of soft tissue to bones Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.