510(k) K253858

GFS - Sterile Screws and Top Hat by T.A.G. Medical Products Corporation, Ltd. — Product Code HWC

K253858 is an FDA 510(k) premarket notification submitted by T.A.G. Medical Products Corporation, Ltd. for the device "GFS - Sterile Screws and Top Hat". The FDA issued a decision of Substantially Equivalent on August 5, 2026. The device falls under product code HWC (Screw, Fixation, Bone), 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.