510(k) K130120

EXTREMITY MEDICAL IP FUSION SYSTEM by Extremity Medical, LLC — Product Code HWC

K130120 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "EXTREMITY MEDICAL IP FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 11, 2013. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.