510(k) K202969

Biomet Microfixation OmniMax MMF System by Biomet Microfixation — Product Code JEY

K202969 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Biomet Microfixation OmniMax MMF System". The FDA issued a decision of Substantially Equivalent on August 5, 2021. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Biomet Microfixation has at least 10 other 510(k) clearances on record.