510(k) K000616 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828
| Applicant | Bionx Implants, Ltd., Tampere, FI |
| Decision | Substantially Equivalent, Mar 23, 2000 |
| Received | Feb 24, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000616
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.