510(k) K963118

EXTREMITY BONE SCREW by Acu Med, Inc. — Product Code HWC

K963118 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "EXTREMITY BONE SCREW". The FDA issued a decision of SN on October 10, 1996. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Acu Med, Inc. has at least 10 other 510(k) clearances on record.