510(k) K931652

ACE 6.5 MM BONE SCREW by Ace Medical Co. — Product Code HWC

K931652 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "ACE 6.5 MM BONE SCREW". The FDA issued a decision of SN on April 28, 1994. 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.