510(k) K141527

DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM by Synthes USA — Product Code HRS

K141527 is an FDA 510(k) premarket notification submitted by Synthes USA for the device "DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM". The FDA issued a decision of Substantially Equivalent on March 30, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes USA has at least 10 other 510(k) clearances on record.