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510(k) Data Aggregation

    K Number
    K081149
    Device Name
    BIOPRO GO-EZ SCREW
    Manufacturer
    BIOPRO, INC.
    Date Cleared
    2008-08-05

    (105 days)

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

    BIOPRO GO-EZ SCREW

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

    Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and tendon reattachment. It is intended for but not limited to hand surgery, orthopedic surgery, plastic surgery and podiatric surgery but is not intended for use in the spine.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the BioPro Go-Ez Screw. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence, not on performance studies with specific acceptance criteria.

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