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510(k) Data Aggregation

    K Number
    K970036
    Device Name
    FIXATION PIN OR ROD
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    1997-03-25

    (81 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K953194
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K953194

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

    Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization.

    Device Description

    The Surgical Dynamics™ Bone Pin** is a resorbable fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires.

    AI/ML Overview

    I apologize, but the provided text describes a medical device (Surgical Dynamics™ Bone Pin) and its intended use, materials, and predicate device. It is a 510(k) premarket notification summary from 1997.

    This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt (e.g., MRMC studies, standalone performance, training set details).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input, as the necessary information is completely absent.

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