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510(k) Data Aggregation

    K Number
    K971692
    Device Name
    OSTEOPOWER SYSTEM AND ACCESSORIES
    Manufacturer
    OSTEOMED CORP.
    Date Cleared
    1997-06-27

    (51 days)

    Product Code
    KMW
    Regulation Number
    872.4120
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OSTEOPOWER SYSTEM AND ACCESSORIES

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

    Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.

    Device Description

    OsteoPower System and Accessories

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notification for the "OsteoPower System and Accessories" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

    The document is a letter from the FDA to Osteomed Corporation, dated June 27, 1997, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and provides contact information for further guidance. The "Indications for Use" are also described.

    Therefore, I cannot provide the requested information based on the provided input.

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