510(k) K111550

SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) by Sonoma Orthopedic Products, Inc. — Product Code HSB

K111550 is an FDA 510(k) premarket notification submitted by Sonoma Orthopedic Products, Inc. for the device "SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)". The FDA issued a decision of Substantially Equivalent on Aug 19, 2011. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Sonoma Orthopedic Products, Inc. has 8 other 510(k) clearances on record.