510(k) K100112

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

K100112 is an FDA 510(k) premarket notification submitted by Sonoma Orthopedic Products, Inc. for the device "SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)". The FDA issued a decision of Substantially Equivalent on Sep 28, 2010. 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.