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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 / January 2026 / K253618

510(k) cleared

QuadLock Fixation System

Abanza Tecnomed S.L · Jan 6, 2026 · K253618

FDA cleared the QuadLock Fixation System from Abanza Tecnomed S.L on Jan 6, 2026 under K253618, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 18, 2025. The decision came 49 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253618?

K253618 is the FDA 510(k) for QuadLock Fixation System, submitted by Abanza Tecnomed S.L. FDA's decision date was Jan 6, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the QuadLock Fixation System?

Abanza Tecnomed S.L, based in Mutilva, is the applicant of record for K253618.

How long did the K253618 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Jan 6, 2026, 49 days later.

← All decisions in January 2026