510(k) K070389 ยท HWC Screw, Fixation, Bone
PEEK KNOTLESS ANCHORS
| Applicant | Biomet Sports Medicine, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 9, 2007 |
| Received | Feb 9, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2009 | Biomet, Inc. Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P.
Intended to be implanted for fixation of bone fractures and for bone reco Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.