510(k) K112812

LEFORTE NEURO SYSTEM BONE PLATE by Jeil Medical Corporation — Product Code GWO

K112812 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "LEFORTE NEURO SYSTEM BONE PLATE". The FDA issued a decision of Substantially Equivalent on Feb 22, 2012. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Jeil Medical Corporation has 52 other 510(k) clearances on record.