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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 / June 2026 / K253108

510(k) cleared

VEOFIX Snap Off Screw

Steps Ortho · Jun 5, 2026 · K253108

FDA cleared the VEOFIX Snap Off Screw from Steps Ortho on Jun 5, 2026 under K253108, a traditional 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 Sep 24, 2025. The decision came 254 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 Steps Ortho in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253108?

K253108 is the FDA 510(k) for VEOFIX Snap Off Screw, submitted by Steps Ortho. FDA's decision date was Jun 5, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the VEOFIX Snap Off Screw?

Steps Ortho, based in Bron, is the applicant of record for K253108.

How long did the K253108 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Jun 5, 2026, 254 days later.

← All decisions in June 2026