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510(k) Data Aggregation

    K Number
    K061910
    Device Name
    SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2006-09-21

    (77 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K061910
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes Angular Stable Locking System (ASLS) is indicated for use with Synthes Titanium Intramedullary Nails to achieve angular and axial stable locking.

    Device Description

    Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for interlocking Synthes Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a premounted peek sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 26 mm - 125 mm.

    AI/ML Overview

    This document is a 510(k) summary for the Synthes Angular Stable Locking System (ASLS). It details the device's classification, description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot fulfill your request for the specific details outlined concerning acceptance criteria and study results. This type of regulatory submission typically focuses on demonstrating equivalence to previously cleared devices rather than providing detailed clinical study results or performance metrics against defined acceptance criteria.

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