510(k) K083240 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
| Applicant | Arthrocare Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 12, 2009 |
| Received | Nov 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor
Intended for rotator cuff repair in the shoulder. Terminated |
MBI | None listed |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits
Intended for rotator cuff repair. Terminated |
MBI | None listed |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502
Intended for rotator cuff repair Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.