510(k) K954485

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

K954485 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "6.5MM SOLID CANCELLOUS BONE SCREW". The FDA issued a decision of Substantially Equivalent on October 31, 1995. 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.