510(k) K953198

CORTICELLOUS BONE SCREW by Hayes Medical, Inc. — Product Code HWC

K953198 is an FDA 510(k) premarket notification submitted by Hayes Medical, Inc. for the device "CORTICELLOUS BONE SCREW". The FDA issued a decision of SN on November 24, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Hayes Medical, Inc. has at least 10 other 510(k) clearances on record.