510(k) K912640

CONCEPT ENDOSTEAL FIXATION DEVICE by Concept, Inc. — Product Code HWC

K912640 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "CONCEPT ENDOSTEAL FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on May 1, 1992. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Concept, Inc. has at least 10 other 510(k) clearances on record.