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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 / October 2025 / K252153

510(k) cleared

FFX Facet Fixation System

Sc Medica · Oct 16, 2025 · K252153

FDA cleared the FFX Facet Fixation System from Sc Medica on Oct 16, 2025 under K252153, a traditional 510(k). The device falls under product code MRW, System, Facet Screw Spinal Device as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Jul 9, 2025. The decision came 99 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sc Medica has 2 other decisions in the tracker over the last 12 months: K250679 (FFX Facet Fixation System), K243920 (Purema H Hemoconcentrator - Pediatric).

Questions & Answers

What did FDA clear under K252153?

K252153 is the FDA 510(k) for FFX Facet Fixation System, submitted by Sc Medica. FDA's decision date was Oct 16, 2025, under product code MRW (System, Facet Screw Spinal Device).

Who makes the FFX Facet Fixation System?

Sc Medica, based in Strasbourg, is the applicant of record for K252153.

How long did the K252153 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Oct 16, 2025, 99 days later.

← All decisions in October 2025

Sources