510(k) K163579

KLS Martin Individual Patient Solutions by KLS Martin L.P. — Product Code JEY

K163579 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "KLS Martin Individual Patient Solutions". The FDA issued a decision of Substantially Equivalent on November 21, 2017. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. KLS Martin L.P. has at least 10 other 510(k) clearances on record.