510(k) K131445

OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM by Osteomed LP — Product Code HRS

K131445 is an FDA 510(k) premarket notification submitted by Osteomed LP for the device "OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 18, 2013. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Osteomed LP has at least 10 other 510(k) clearances on record.