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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 / November 2025 / K252327

510(k) cleared

CMORE® CT System; CMORE® CT System Navigated Instruments

Icotec AG · Nov 12, 2025 · K252327

FDA cleared the CMORE® CT System; CMORE® CT System Navigated Instruments from Icotec AG on Nov 12, 2025 under K252327, a traditional 510(k). The device falls under product code NKG, Posterior Cervical Screw System, regulated at 21 CFR 888.3075 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 25, 2025. The decision came 110 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 Icotec AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252327?

K252327 is the FDA 510(k) for CMORE® CT System; CMORE® CT System Navigated Instruments, submitted by Icotec AG. FDA's decision date was Nov 12, 2025, under product code NKG (Posterior Cervical Screw System).

Who makes the CMORE® CT System; CMORE® CT System Navigated Instruments?

Icotec AG, based in Altstaetten, is the applicant of record for K252327.

How long did the K252327 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Nov 12, 2025, 110 days later.

← All decisions in November 2025