510(k) K912598

ACE CORTICAL BONE SCREW by Ace Medical Co. — Product Code HWC

K912598 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "ACE CORTICAL BONE SCREW". The FDA issued a decision of SN on November 27, 1991. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ace Medical Co. has at least 10 other 510(k) clearances on record.