510(k) K101934

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 by Medshape Solutions — Product Code HSB

K101934 is an FDA 510(k) premarket notification submitted by Medshape Solutions for the device "DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000". The FDA issued a decision of Substantially Equivalent on August 3, 2011. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Medshape Solutions has at least 5 other 510(k) clearances on record.