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510(k) Data Aggregation

    K Number
    K974409
    Manufacturer
    Date Cleared
    1998-02-19

    (87 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRIEDL GLIDING NAIL SYSTEM

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

    The Friedl Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:

    • pertrochanteric femoral fractures -
    • subtrochanteric femoral fractures and -
    • lateral femoral neck fractures. -

    Internal fixation with the long Fried! Gliding Nail is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the Friedl Gliding Nail system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weightbearing stability after varus and valgus revision osteotomies of the proximal femur.

    Device Description

    The FRIEDL Gliding Nail System is an all-purpose locking nail system for primary load stability in pertrochanteric femoral fractures, subtrochanteric femoral fractures, and lateral femoral neck fractures. This system consists of several sizes of intramedullary nails, femoral neck blades, and distal locking pins. The Fried Gliding Nail System is made of Wrought High Nitrogen Stainless Steel according to ISO 5832-9.

    AI/ML Overview

    The provided text is a 510(k) summary for the FRIEDL Gliding Nail System, a medical device for orthopedic fixation. It discusses the device's description, indications for use, and its substantial equivalence to a predicate device.

    However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. It is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a report of a clinical or performance study with defined acceptance criteria.

    Therefore, I cannot provide the requested table and study details from the given input.

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