WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / January 2026 / K253941

510(k) cleared

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)

Medtronic Sofamor Danek USA, Inc. · Jan 7, 2026 · K253941

FDA cleared the CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) from Medtronic Sofamor Danek USA, Inc. on Jan 7, 2026 under K253941, a special 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 Dec 9, 2025. The decision came 29 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), K260216 (CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System).

Questions & Answers

What did FDA clear under K253941?

K253941 is the FDA 510(k) for CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly), submitted by Medtronic Sofamor Danek USA, Inc.. FDA's decision date was Jan 7, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)?

Medtronic Sofamor Danek USA, Inc., based in Memphis, TN, is the applicant of record for K253941.

How long did the K253941 review take?

FDA received the submission on Dec 9, 2025 and issued its decision on Jan 7, 2026, 29 days later.

← All decisions in January 2026