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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 / K261020

510(k) cleared

Symmetrix L Spinal System

Medtronic Sofamor Danek USA, Inc. · Jul 14, 2026 · K261020

FDA cleared the Symmetrix L Spinal System from Medtronic Sofamor Danek USA, Inc. on Jul 14, 2026 under K261020, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 27, 2026. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Sofamor Danek USA, Inc. has 7 other decisions in the tracker over the last 12 months: K253011 (Catalyft PL Expandable Interbody System), K253656 (OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System), K260216 (CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System), K254165 (Infinity OCT System).

Questions & Answers

What did FDA clear under K261020?

K261020 is the FDA 510(k) for Symmetrix L Spinal System, submitted by Medtronic Sofamor Danek USA, Inc.. FDA's decision date was Jul 14, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Symmetrix L Spinal System?

Medtronic Sofamor Danek USA, Inc., based in Memphis, TN, is the applicant of record for K261020.

How long did the K261020 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Jul 14, 2026, 109 days later.

← All decisions in July 2026