510(k) K993465

DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE by Depuy, Inc. — Product Code HRS

K993465 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE". The FDA issued a decision of Substantially Equivalent on January 11, 2000. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Depuy, Inc. has at least 10 other 510(k) clearances on record.