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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 / K253523

510(k) cleared

Freedom DS Decompression System

Spinal Simplicity · Apr 16, 2026 · K253523

FDA cleared the Freedom DS Decompression System from Spinal Simplicity on Apr 16, 2026 under K253523, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 13, 2025. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spinal Simplicity has one other decision in the tracker over the last 12 months: K253250 (Minuteman® G6 MIS Fusion Plate).

Questions & Answers

What did FDA clear under K253523?

K253523 is the FDA 510(k) for Freedom DS Decompression System, submitted by Spinal Simplicity. FDA's decision date was Apr 16, 2026, under product code HRX (Arthroscope).

Who makes the Freedom DS Decompression System?

Spinal Simplicity, based in Overland Park, KS, is the applicant of record for K253523.

How long did the K253523 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Apr 16, 2026, 154 days later.

← All decisions in April 2026

Sources