510(k) K212841

Pectus Blu Support Bar System by Biomet Micofixation — Product Code HRS

K212841 is an FDA 510(k) premarket notification submitted by Biomet Micofixation for the device "Pectus Blu Support Bar System". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Biomet Micofixation has at least 2 other 510(k) clearances on record.