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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 / K260216

510(k) cleared

CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System

Medtronic Sofamor Danek USA, Inc. · Apr 21, 2026 · K260216

FDA cleared the CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System from Medtronic Sofamor Danek USA, Inc. on Apr 21, 2026 under K260216, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 23, 2026. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic Sofamor Danek USA, Inc. has 7 other decisions in the tracker over the last 12 months: K253011 (Catalyft PL Expandable Interbody System), K261020 (Symmetrix L Spinal System), K253656 (OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System), K254165 (Infinity OCT System).

Questions & Answers

What did FDA clear under K260216?

K260216 is the FDA 510(k) for CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System, submitted by Medtronic Sofamor Danek USA, Inc.. FDA's decision date was Apr 21, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System?

Medtronic Sofamor Danek USA, Inc., based in Memphis, TN, is the applicant of record for K260216.

How long did the K260216 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on Apr 21, 2026, 88 days later.

← All decisions in April 2026