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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 / April 2026 / K253042

510(k) cleared

Tyber Medical Trauma Screw

Tyber Medical, LLC · Apr 3, 2026 · K253042

FDA cleared the Tyber Medical Trauma Screw from Tyber Medical, LLC on Apr 3, 2026 under K253042, 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 22, 2025. The decision came 193 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tyber Medical, LLC has 5 other decisions in the tracker over the last 12 months: K261207 (Exalta Proximal Tibia Plating System), K260810 (Anteralign LS coverplate), K261060 (Navigated LLIF Impactable Tracker), K252901 (Tyber Medical Trauma Screw).

Questions & Answers

What did FDA clear under K253042?

K253042 is the FDA 510(k) for Tyber Medical Trauma Screw, submitted by Tyber Medical, LLC. FDA's decision date was Apr 3, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the Tyber Medical Trauma Screw?

Tyber Medical, LLC, based in Bethlehem, PA, is the applicant of record for K253042.

How long did the K253042 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Apr 3, 2026, 193 days later.

← All decisions in April 2026

Sources