510(k) K123723

SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM by Synthes — Product Code GWO

K123723 is an FDA 510(k) premarket notification submitted by Synthes for the device "SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 5, 2013. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Synthes has at least 10 other 510(k) clearances on record.