510(k) K061763 ยท HWC Screw, Fixation, Bone
ARC SURGICAL BIOTRAK SCREW
| Applicant | Arc Surgical, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Sep 19, 2006 |
| Received | Jun 22, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2009 | Acumed LLC Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320- Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.