510(k) K121417

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM by Extremity Medical, LLC — Product Code HWC

K121417 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 2012. 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.