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    K Number
    K042310
    Device Name
    ORTHO-PRO CANNULATED BONE SCREWS
    Manufacturer
    ORTHO-PRO LLC
    Date Cleared
    2004-09-16

    (22 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K991151
    Why did this record match?
    Device Name :

    ORTHO-PRO CANNULATED BONE SCREWS

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

    The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.

    These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

    Device Description

    The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. These screws are of the self-tapping type. This device is manufactured from Ti-6A1-4V alloy and is available in a variety of sizes.

    AI/ML Overview

    This 510(k) summary describes a bone screw, which is a physical medical device, not an AI/ML enabled device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device based on material, indications for use, and similar thread form, which are criteria relevant to physical orthopedic implants.

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