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510(k) Data Aggregation

    K Number
    K090241
    Device Name
    SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2009-06-17

    (135 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K103002,K120807
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Synthes Angular Stable Locking System (ASLS), when used with Synthes Cannulated Titanium Intramedullary Nails, is intended to aid in the alignment and stabilization of tibial, humeral, femoral, and ankle fractures.

    Device Description

    The Synthes Angular Stable Locking System (ASLS) is designed as an alternative device for the interlocking of Synthes Cannulated Titanium Intramedullary Nails. The ASLS consists of a titanium screw with a 70:30 Poly (L/DL-Lactide) sleeve and is available in diameters ranging between 4.0 mm - 6.0 mm and overall lengths ranging between 23 mm - 125 mm.

    AI/ML Overview

    The provided text is a 510(k) summary for the Synthes Angular Stable Locking System (ASLS). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. This document is a regulatory submission and approval letter, not a detailed study report.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The requested information is simply not present in this document.

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