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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 / December 2025 / K253250

510(k) cleared

Minuteman® G6 MIS Fusion Plate

Spinal Simplicity, LLC · Dec 1, 2025 · K253250

FDA cleared the Minuteman® G6 MIS Fusion Plate from Spinal Simplicity, LLC on Dec 1, 2025 under K253250, a traditional 510(k). The device falls under product code PEK, Spinous Process Plate, regulated at 21 CFR 888.3050 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Spinal Simplicity, LLC has one other decision in the tracker over the last 12 months: K253523 (Freedom DS Decompression System).

Questions & Answers

What did FDA clear under K253250?

K253250 is the FDA 510(k) for Minuteman® G6 MIS Fusion Plate, submitted by Spinal Simplicity, LLC. FDA's decision date was Dec 1, 2025, under product code PEK (Spinous Process Plate).

Who makes the Minuteman® G6 MIS Fusion Plate?

Spinal Simplicity, LLC, based in Overland Park, KS, is the applicant of record for K253250.

How long did the K253250 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 1, 2025, 63 days later.

← All decisions in December 2025

Sources