510(k) K141123

ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM by Alliance Partners, LLC — Product Code GWO

K141123 is an FDA 510(k) premarket notification submitted by Alliance Partners, LLC for the device "ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 2015. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Alliance Partners, LLC has at least 9 other 510(k) clearances on record.