510(k) K945687

ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW by Smith And Nephew Donjoy, Inc. — Product Code HWC

K945687 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW". The FDA issued a decision of Substantially Equivalent for Some Indications on Jun 22, 1995. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.