Meniscus Versaflex
K-Number: K254188 · 2026-02-19
Decision Date2026-02-19
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Meniscus Versaflex is a medical device manufactured by GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2026-02-19 under approval number K254188. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Meniscus Versaflex?
Meniscus Versaflex is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K254188.
When was Meniscus Versaflex approved by the FDA?
Meniscus Versaflex received FDA 510(k) clearance on 2026-02-19, under approval number K254188.
What company makes Meniscus Versaflex?
Meniscus Versaflex is manufactured by GM Dos Reis Industria e Comercio Ltda..
What is the FDA product code for Meniscus Versaflex?
The FDA product code for Meniscus Versaflex is GAT.
Other Devices by GM Dos Reis Industria e Comercio Ltda.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.