510(k) K142653

G-Lok and G-Lok XL Extender by T.A.G. Medical Products Corporation, Ltd. — Product Code MBI

K142653 is an FDA 510(k) premarket notification submitted by T.A.G. Medical Products Corporation, Ltd. for the device "G-Lok and G-Lok XL Extender". The FDA issued a decision of Substantially Equivalent on October 16, 2014. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. T.A.G. Medical Products Corporation, Ltd. has at least 10 other 510(k) clearances on record.