510(k) K042966 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
| Applicant | Linvatec Biomaterials, Ltd., Tampere, FI |
| Decision | Substantially Equivalent, Nov 19, 2004 |
| Received | Oct 28, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042966
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.