510(k) K013546 ยท HWC Screw, Fixation, Bone
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
| Applicant | Bionx Implants, Inc., Tampere, FI |
| Decision | Substantially Equivalent, Nov 21, 2001 |
| Received | Oct 24, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013546
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.