510(k) K001378 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
| Applicant | Bionx Implants, Inc., Tampere, FI |
| Decision | Substantially Equivalent, Jul 28, 2000 |
| Received | May 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001378
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.