510(k) K992396

BIORCI SCREW by Smith & Nephew Endoscopy, Inc. — Product Code HWC

K992396 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "BIORCI SCREW". The FDA issued a decision of Substantially Equivalent on January 12, 2000. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.