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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 / July 2026 / K261406

510(k) cleared

Versalock Proximal Tibial Plating System

GM Dos Reis Industria e Comercio Ltda. · Jul 21, 2026 · K261406

FDA cleared the Versalock Proximal Tibial Plating System from GM Dos Reis Industria e Comercio Ltda. on Jul 21, 2026 under K261406, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 29, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

GM Dos Reis Industria e Comercio Ltda. has 4 other decisions in the tracker over the last 12 months: K260390 (Super Upper Limbs Versalock Plating System), K254188 (Meniscus Versaflex), K251050 (Pectus Versa System), K252664 (GMReis Suture Anchors).

Questions & Answers

What did FDA clear under K261406?

K261406 is the FDA 510(k) for Versalock Proximal Tibial Plating System, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Jul 21, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Versalock Proximal Tibial Plating System?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K261406.

How long did the K261406 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on Jul 21, 2026, 83 days later.

← All decisions in July 2026

Sources