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510(k) Data Aggregation

    K Number
    K260390

    Validate with FDA (Live)

    Device Name
    Super Upper Limbs Versalock Plating System
    Manufacturer
    GM Dos Reis Industria e Comercio Ltda.
    Date Cleared
    2026-03-17

    (39 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    22 - 120
    Reference & Predicate Devices
    K232829,K182718,K242596,K142906,K123241,K172170,K142419,K000684,K141232,K951302
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Super Upper Limbs Versalock Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand, wrist and forearm. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

    Device Description

    The Super Upper Limbs Versalock Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from commercial titanium alloy and pure titanium. The plates range in thickness from 0.6 to 4.0 mm, and the screws range in diameter from 2.0 to 3.5 mm.

    Super Upper Limbs Versalock Plating System implants are manufactured with the following raw materials:

    • Titanium Alloy Ti6Al4V according to ASTM F136
    • Pure Titanium according to ASTM F67
    AI/ML Overview

    N/A

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