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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 / K250197

510(k) cleared

Estremo Fibular Nail

Citieffe S.R.L. · Oct 17, 2025 · K250197

FDA cleared the Estremo Fibular Nail from Citieffe S.R.L. on Oct 17, 2025 under K250197, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 23, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Citieffe S.R.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250197?

K250197 is the FDA 510(k) for Estremo Fibular Nail, submitted by Citieffe S.R.L.. FDA's decision date was Oct 17, 2025, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Estremo Fibular Nail?

Citieffe S.R.L., based in Calderara Di Reno, is the applicant of record for K250197.

How long did the K250197 review take?

FDA received the submission on Jan 23, 2025 and issued its decision on Oct 17, 2025, 267 days later.

← All decisions in October 2025