510(k) K163007

Biomet Microfixation SternaLock 360 Sternal Closure System by Biomet Microfixation — Product Code HRS

K163007 is an FDA 510(k) premarket notification submitted by Biomet Microfixation for the device "Biomet Microfixation SternaLock 360 Sternal Closure System". The FDA issued a decision of Substantially Equivalent on November 23, 2016. 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.