510(k) K052150

VOLAR PLATE SYSTEM by Dvo Extremity Solutions, LLC — Product Code HRS

K052150 is an FDA 510(k) premarket notification submitted by Dvo Extremity Solutions, LLC for the device "VOLAR PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 2005. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Dvo Extremity Solutions, LLC has at least 3 other 510(k) clearances on record.