510(k) K130731

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW by Stabiliz Orthopaedics, LLC — Product Code HRS

K130731 is an FDA 510(k) premarket notification submitted by Stabiliz Orthopaedics, LLC for the device "STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW". The FDA issued a decision of Substantially Equivalent on July 19, 2013. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stabiliz Orthopaedics, LLC has at least 3 other 510(k) clearances on record.