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510(k) Data Aggregation

    K Number
    K052576
    Device Name
    SBI AUTOFIX
    Manufacturer
    SMALL BONE INNOVATIONS, LLC
    Date Cleared
    2005-11-07

    (49 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SBI AUTOFIX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.

    Device Description

    The SBI AutoFix™ System consists of a series of Cannulated and Non-Cannulated bone screws varying in length and diameter. The SBI AutoFix™ System is intended for use on selected fractures in the body as medically indicated and bone mass compatible.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a medical device called the "SBI AutoFix™ System" and primarily discusses its regulatory clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    Therefore, I cannot provide the requested table and information based on the given input. The document is a regulatory approval letter, not a technical performance study report.

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