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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 / July 2026 / K261058

510(k) cleared

CraniUS Plate

CraniUS, LLC · Jul 29, 2026 · K261058

FDA cleared the CraniUS Plate from CraniUS, LLC on Jul 29, 2026 under K261058, a traditional 510(k). The device falls under product code GWO, Plate, Cranioplasty, Preformed, Alterable, regulated at 21 CFR 882.5320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 31, 2026. The decision came 120 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 CraniUS, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261058?

K261058 is the FDA 510(k) for CraniUS Plate, submitted by CraniUS, LLC. FDA's decision date was Jul 29, 2026, under product code GWO (Plate, Cranioplasty, Preformed, Alterable).

Who makes the CraniUS Plate?

CraniUS, LLC, based in Baltimore, MD, is the applicant of record for K261058.

How long did the K261058 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Jul 29, 2026, 120 days later.

← All decisions in July 2026