510(k) K261002

Pectus Blu System by Biomet Microfixation — Product Code HRS

K261002 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Pectus Blu System". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biomet Microfixation has at least 10 other 510(k) clearances on record.