510(k) K862254

WARSAW ORTHOPEDIC BONE PLATE by Warsaw Orthopedic, Inc. — Product Code HRS

K862254 is an FDA 510(k) premarket notification submitted by Warsaw Orthopedic, Inc. for the device "WARSAW ORTHOPEDIC BONE PLATE". The FDA issued a decision of Substantially Equivalent on July 8, 1986. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Warsaw Orthopedic, Inc. has at least 10 other 510(k) clearances on record.