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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 / January 2026 / K254165

510(k) cleared

Infinity OCT System

Medtronic Sofamor Danek USA, Inc. · Jan 21, 2026 · K254165

FDA cleared the Infinity OCT System from Medtronic Sofamor Danek USA, Inc. on Jan 21, 2026 under K254165, a special 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 Dec 22, 2025. The decision came 30 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 K254165?

K254165 is the FDA 510(k) for Infinity OCT System, submitted by Medtronic Sofamor Danek USA, Inc.. FDA's decision date was Jan 21, 2026, under product code NKG (Posterior Cervical Screw System).

Who makes the Infinity OCT System?

Medtronic Sofamor Danek USA, Inc., based in Memphis, TN, is the applicant of record for K254165.

How long did the K254165 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Jan 21, 2026, 30 days later.

← All decisions in January 2026