510(k) K972599

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

K972599 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "ACUFEX SCREW CANNULA". The FDA issued a decision of Substantially Equivalent on September 19, 1997. 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.