510(k) K042584 ยท HWC Screw, Fixation, Bone
OPUS MINIMAGNUM ANCHOR WITH INSERTER
| Applicant | Opus Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Dec 14, 2004 |
| Received | Sep 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Innovatech Medical Resources L.P. 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal
Intended for rotator cuff repair. Terminated |
MBI | None listed |
| Jan 11, 2012 | Innovatech Medical Resources L.P. OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor
Intended for rotator cuff repair Terminated |
HWC | None listed |
| Oct 14, 2011 | ArthroCare Corporation ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007;
Product is manufactured and distributed by Ar Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.