510(k) K182492

Geminus Volar Distal Radius Plate System by Skeletal Dynamics, LLC — Product Code HRS

K182492 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, LLC for the device "Geminus Volar Distal Radius Plate System". The FDA issued a decision of Substantially Equivalent on Oct 10, 2018. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Skeletal Dynamics, LLC has 39 other 510(k) clearances on record.