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510(k) Data Aggregation

    K Number
    K254054

    Validate with FDA (Live)

    Device Name
    VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System
    Manufacturer
    Synthes GmbH
    Date Cleared
    2026-03-02

    (75 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    12 - 21
    Reference & Predicate Devices
    K011335,K991407,K063049,K211051
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VOLT™ Ankle Trauma 2.7/3.5 Plating System

    The VOLT™ Ankle Trauma 2.7/3.5 Plating System is indicated for fractures, non-unions and deformity corrections in the distal tibia and distal fibula.

    The VOLT™ Ankle Trauma 2.7/3.5 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.

    VOLT™ Calcaneus 2.7 Plating System

    The VOLT™ Calcaneus 2.7 Plating System is indicated for fractures, non-unions and deformity corrections in the calcaneus

    The VOLT™ Calcaneus 2.7 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.

    Device Description

    VOLT™ Ankle Trauma 2.7/3.5 Plating System

    The VOLT™ Ankle Trauma 2.7/3.5 Plating System is a family of implantable devices consisting of 2.7mm, 2.7mm/3.5mm and 3.5 mm anatomic and non-anatomic plates with variable angle screw holes. The plates of this system are available in Stainless Steel. Plates within the VOLT™ Ankle Trauma 2.7/3.5 Plating System are available non-sterile and are single-use only.

    VOLT™ Calcaneus 2.7 Plating System

    The VOLT™ Calcaneus 2.7 Plating System is a family of implantable devices consisting of 2.7mm anatomic plates with variable angle screw holes. The plates of this system are available in Stainless Steel. Plates within the VOLT™ Calcaneus 2.7 Plating System are available non-sterile and are single-use only.

    AI/ML Overview

    N/A

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