510(k) K250988

KLS Martin Pure Pectus System by KLS-Martin L.P. — Product Code HRS

K250988 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "KLS Martin Pure Pectus System". The FDA issued a decision of Substantially Equivalent on December 11, 2025. 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.