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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 / March 2026 / K260390

510(k) cleared

Super Upper Limbs Versalock Plating System

GM Dos Reis Industria e Comercio Ltda. · Mar 17, 2026 · K260390

FDA cleared the Super Upper Limbs Versalock Plating System from GM Dos Reis Industria e Comercio Ltda. on Mar 17, 2026 under K260390, 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 Feb 6, 2026. The decision came 39 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: K261406 (Versalock Proximal Tibial Plating System), K254188 (Meniscus Versaflex), K251050 (Pectus Versa System), K252664 (GMReis Suture Anchors).

Questions & Answers

What did FDA clear under K260390?

K260390 is the FDA 510(k) for Super Upper Limbs Versalock Plating System, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Mar 17, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Super Upper Limbs Versalock Plating System?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K260390.

How long did the K260390 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Mar 17, 2026, 39 days later.

← All decisions in March 2026

Sources