510(k) K101934 ยท HSB Rod, Fixation, Intramedullary And Accessories
DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
| Applicant | Medshape Solutions, Atlanta GA, US |
| Decision | Substantially Equivalent, Aug 3, 2011 |
| Received | Jul 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101934
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.