510(k) K141301

MAXLOCK EXTREME ELBOW FRACTURE SYSTEM by Orthohelix Surgical Designs, Inc. — Product Code HRS

K141301 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "MAXLOCK EXTREME ELBOW FRACTURE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 11, 2014. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthohelix Surgical Designs, Inc. has at least 10 other 510(k) clearances on record.