510(k) K012001 ยท HWC Screw, Fixation, Bone
SMARTSCREW
| Applicant | Bionx Implants, Ltd., Tampere, FI |
| Decision | Substantially Equivalent, Jul 18, 2001 |
| Received | Jun 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012001
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.