510(k) K213712

Pectus Support Bar System by Biomet Microfixation — Product Code HRS

K213712 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Pectus Support Bar System". The FDA issued a decision of Substantially Equivalent on March 11, 2022. 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.