510(k) K052810 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
| Applicant | Scandius Biomedical, Inc., Littleton MA, US |
| Decision | Substantially Equivalent, Dec 20, 2005 |
| Received | Oct 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052810
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.