510(k) K981715

DISTAL RADIUS FRACTURE FIXATION PLATE by Avanta Orthopaedics, Inc. — Product Code HRS

K981715 is an FDA 510(k) premarket notification submitted by Avanta Orthopaedics, Inc. for the device "DISTAL RADIUS FRACTURE FIXATION PLATE". The FDA issued a decision of Substantially Equivalent on July 29, 1998. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Avanta Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.