510(k) K191028

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

K191028 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 22, 2019. 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.