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510(k) Data Aggregation

    K Number
    K260274

    Validate with FDA (Live)

    Device Name
    Airlock® Ankle Plating System
    Manufacturer
    Novastep SAS
    Date Cleared
    2026-03-25

    (55 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Abbreviated
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K121425,K250952,K143523
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Airlock® Ankle Plating System is indicated for arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints, involving osteotomies of the distal tibia, talus, and calcaneus.

    The system can be used in adult patients.

    Device Description

    Airlock® Ankle Plating System is a range of implantable devices, made of titanium alloy, designed to treat ankle-related indications. Each implant is provided as a single-use sterile device.

    The Airlock® Ankle Plating system range is constituted by 3 plates variants with holes, available in left and right option for anatomical adaptation. Screws for the fixation and the stabilization of the airlock ankle plates are available in 4 different variants (Locking polyaxial screws Ø4 or Ø4.7 and non-locking screws Ø4 or Ø4.7) and are available in lengths from 14 to 60mm.

    AI/ML Overview

    N/A

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