510(k) K013057 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
BIOCUFF,C, MODELS 236018, 236028, 236036
| Applicant | Bionx Implants, Inc., Tampere, FI |
| Decision | Substantially Equivalent, Oct 12, 2001 |
| Received | Sep 12, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013057
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.