510(k) K083154

NEWDEAL HALLU LOCK PLATE SYSTEM by Newdeal Sas — Product Code HRS

K083154 is an FDA 510(k) premarket notification submitted by Newdeal Sas for the device "NEWDEAL HALLU LOCK PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 10, 2009. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Newdeal Sas has at least 9 other 510(k) clearances on record.