510(k) K161259

KLS Martin Cannulated Headless Screws by KLS Martin L.P. — Product Code HWC

K161259 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS Martin Cannulated Headless Screws". The FDA issued a decision of Substantially Equivalent on December 19, 2016. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. KLS Martin L.P. has at least 10 other 510(k) clearances on record.