510(k) K102539 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM
| Applicant | Shoulder Options, Inc., Waxhaw NC, US |
| Decision | Substantially Equivalent, Feb 24, 2011 |
| Received | Sep 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102539
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.