510(k) K961649

ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER by Smith & Nephew Endoscopy, Inc. — Product Code HWC

K961649 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER". The FDA issued a decision of SN on July 16, 1996. 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.