510(k) K063589 ยท HWC Screw, Fixation, Bone
GSO BONE FIXATION FASTENERS
| Applicant | Gold Standard Orthopaedics, LLC, Louisville KY, US |
| Decision | Substantially Equivalent, Jan 31, 2007 |
| Received | Dec 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063589
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.