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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262537

510(k) cleared

Versalock Sterile Plating System

GM Dos Reis Industria e Comercio Ltda. · Aug 19, 2026 · K262537

FDA cleared the Versalock Sterile Plating System from GM Dos Reis Industria e Comercio Ltda. on Aug 19, 2026 under K262537, a special 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 Jul 23, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

GM Dos Reis Industria e Comercio Ltda. has 6 other decisions in the tracker over the last 12 months: K253910 (Stitch - Suture Wires and Tapes), K261406 (Versalock Proximal Tibial Plating System), K260390 (Super Upper Limbs Versalock Plating System), K254188 (Meniscus Versaflex).

Questions & Answers

What did FDA clear under K262537?

K262537 is the FDA 510(k) for Versalock Sterile Plating System, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Aug 19, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Versalock Sterile Plating System?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K262537.

How long did the K262537 review take?

FDA received the submission on Jul 23, 2026 and issued its decision on Aug 19, 2026, 27 days later.

← All decisions in August 2026

Sources