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510(k) Data Aggregation

    K Number
    K211439
    Device Name
    Small Bone Nailing System
    Manufacturer
    Skeletal Dynamics, Inc.
    Date Cleared
    2021-09-30

    (143 days)

    Product Code
    HTY,HSB
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K033406
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Skeletal Dynamics Small Bone Nailing System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal phalanges.

    Device Description

    The Skeletal Dynamics Small Bone Nailing System consists of intramedullary nails and screws with diameters of 2.1mm, 3.0mm, and 4.0mm, and lengths from 25mm to 70mm to address proximal phalanx and metacarpal fractures. The intramedullary nails and screws are made of medical grade titanium allov. Cobalt Chrome 1.7mm transfixion screws are also provided in various lengths. Included in the system is specialized instrumentation. The System is provided non-sterile for sterilization in the user facility.

    The Small Bone Nailing System is comprised of:

    • Titanium alloy intramedullary nails and screws
    • CoCr locking screws and transfixion screws
    • Stainless steel K-wires (for provisional fixation: not for implantation)
    • System specific instrumentation
    AI/ML Overview

    This is not an AI/ML device. The document describes a Small Bone Nailing System used for fracture fixation, which is a physical medical device and not a software-based AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable and cannot be extracted from this document.

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