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510(k) Data Aggregation

    K Number
    K971778
    Device Name
    OSTEO SMALL AND MINI BONE SCREWS
    Manufacturer
    OSTEONICS CORP.
    Date Cleared
    1997-06-27

    (44 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The subject Osteo Small and Mini Bone Screws are intended for internal fracture fixation of small bones. Osteo Bone Screws are not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

    Device Description

    Small Cortex Screws:

    The Osteo Small Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread with three cutting grooves. The thread diameter measures 2.5mm, and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 5mm in diameter. The Osteo Small Cortex Screws are available in lengths from 6mm to 40mm.

    Mini Cortex Screws:

    The Osteo Mini Cortex Screws are fabricated from ASTM F-138-92 stainless steel, and are available either with or without a self tapping thread on the self tapping screws features one cutting groove. The thread diameter measures 1.5mm, and the root diameter measures 1.0mm. These bone screws have a conical head underside with a cross slot. The head measures 2.5mm in diameter. The Osteo Mini Cortex Screws with a self tapping thread are available in lengths from 8mm to 22mm. The Osteo Mini Cortex Screws without a self tapping thread are available in lengths from 6mm to 20mm.

    Small Cancellous Screws:

    The Osteo Small Cancellous Screws are fabricated from ASTM F-138-92 stainless steel. The thread diameter measures 4.0mm. and the root diameter measures 1.9mm. These bone screws have a hexagonal head with a spherical underside. The hexagonal head measures 6mm in diameter. The Osteo Small Cancellous Screws are available in lengths from 10mm to 60mm.

    Mini Cancellous Screws:

    The Osteo Mini Cancellous Screws are fabricated from ASTM F-138-92 stainless steel, and feature a self tapping thread. The self tapping thread features one cutting groove. The thread diameter measures 2.2mm, and the root diameter measures 1.1mm. These bone screws have a flat head with a cross slot. The head measures 3.0mm in diameter. The Osteo Mini Cancellous Screws are available in lengths from 8mm to 22mm.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification Summary for medical devices (bone screws) and does not contain information about acceptance criteria or a study proving that an AI or device meets acceptance criteria in the way typically seen for AI/software devices.

    Instead, this document pertains to the regulatory clearance of physical medical devices (bone screws) based on their substantial equivalence to predicate devices, rather than performance metrics from a clinical study for AI.

    Therefore, I cannot extract the requested information regarding acceptance criteria and device performance from this document, as it is not present in the context of AI/software performance. The document focuses on material, design, and intended use equivalence.

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