510(k) K063497 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
| Applicant | Scandius Biomedical, Inc., Littleton MA, US |
| Decision | Substantially Equivalent, Dec 19, 2006 |
| Received | Nov 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063497
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.