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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 / K242303

510(k) cleared

MOD-C

Orthomod, LLC · Apr 1, 2026 · K242303

FDA cleared the MOD-C from Orthomod, LLC on Apr 1, 2026 under K242303, a traditional 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 5, 2024. The decision came 604 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 Orthomod, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K242303?

K242303 is the FDA 510(k) for MOD-C, submitted by Orthomod, LLC. FDA's decision date was Apr 1, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the MOD-C?

Orthomod, LLC, based in Dayton, OH, is the applicant of record for K242303.

How long did the K242303 review take?

FDA received the submission on Aug 5, 2024 and issued its decision on Apr 1, 2026, 604 days later.

← All decisions in April 2026