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510(k) Data Aggregation

    K Number
    K072298
    Device Name
    BIOPRO MEMORY STAPLE, MODELS 18062-18073
    Manufacturer
    BIOPRO, INC.
    Date Cleared
    2007-10-29

    (73 days)

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

    BIOPRO MEMORY STAPLE, MODELS 18062-18073

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies related to the Biopro Memory Staple. The document is a 510(k) premarket notification letter from the FDA, confirming the device's substantial equivalence to legally marketed predicate devices and outlining regulatory requirements. It does not include details on testing, clinical trials, or performance metrics.

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