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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K253858

510(k) cleared

GFS - Sterile Screws and Top Hat

T.A.G. Medical Products Corporation, Ltd. · Aug 5, 2026 · K253858

FDA cleared the GFS - Sterile Screws and Top Hat from T.A.G. Medical Products Corporation, Ltd. on Aug 5, 2026 under K253858, a special 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 3, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for T.A.G. Medical Products Corporation, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253858?

K253858 is the FDA 510(k) for GFS - Sterile Screws and Top Hat, submitted by T.A.G. Medical Products Corporation, Ltd.. FDA's decision date was Aug 5, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the GFS - Sterile Screws and Top Hat?

T.A.G. Medical Products Corporation, Ltd., based in Gaaton Northern, is the applicant of record for K253858.

How long did the K253858 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Aug 5, 2026, 245 days later.

← All decisions in August 2026