510(k) K222624

KLS Martin LINOS Wrist System by KLS-Martin L.P. — Product Code HRS

K222624 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin LINOS Wrist System". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.