Identifiers
- 510(k) Number
- K254188 FDA 510(k)
- FDA Product Code
- GAT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5000 FDA 510(k)
- Regulation Number
- 878.5000 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Meniscus Versaflex is a Class 2 orthopedic device with product code GAT. It is presented in a single-use sterile package and comes with its respective disposable modeler.
The device is manufactured by GM Dos Reis Industria e Comercio Ltda. and is supplied in a single-use sterile format. It received FDA 510(k) clearance with number K254188 on February 19, 2026, after a 58-day FDA review.
Frequently asked questions
What is the Meniscus Versaflex device used for?
The Meniscus Versaflex is a Class 2 orthopedic device with product code GAT, designed for meniscus procedures. It comes with a disposable modeler to assist in surgical applications.
How is the Meniscus Versaflex supplied and is it sterile?
The Meniscus Versaflex is supplied in a single-use sterile package, ensuring sterility for each procedure. It includes its respective disposable modeler for surgical use.
What is the regulatory status of the Meniscus Versaflex?
The Meniscus Versaflex received FDA 510(k) clearance with number K254188 on February 19, 2026, after a 58-day FDA review. It is classified as substantially equivalent under product code GAT.
Who manufactures the Meniscus Versaflex and where is it produced?
The Meniscus Versaflex is manufactured by GM Dos Reis Industria e Comercio Ltda., located in Campinas, Brazil. The company is responsible for the production and distribution of this orthopedic device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF MENISCUS VERSAFLEX - gmreis.com.br, PDF Senior Regulatory Affairs Analyst Avenida Pierre Simon De Laplace, 600 ..., K254188 FDA 510 (k) - Meniscus Versaflex, Meniscus Versaflex 510 (k) K254188 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K254188 | Class II | Active |
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Manufacturer
- Manufacturer
- Gm Dos Reis Industria E Comercio Ltda
- FDA Applicant
- GM Dos Reis Industria e Comercio Ltda.
Sources (1)
- FDA 510(k) K254188 24 fields · synced Sep 24, 2026