510(k) K002775

DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM by Hand Innovations, Inc. — Product Code HRS

K002775 is an FDA 510(k) premarket notification submitted by Hand Innovations, Inc. for the device "DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 5, 2000. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Hand Innovations, Inc. has at least 10 other 510(k) clearances on record.