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510(k) Data Aggregation

    K Number
    K013786
    Device Name
    DRG ORTHOHEX SS BONE SCREW
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2001-12-17

    (33 days)

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

    DRG ORTHOHEX SS BONE SCREW

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

    The DRG OrthoHex SS bone screws are intended for orthopedic trauma and reconstruction.

    Device Description

    DRG OrthoHex SS Bone Screw

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a medical device (DRG Orthohex SS Bone Screw). It does not contain any information regarding acceptance criteria, device performance studies, or AI/software validation.

    Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on clinical performance or AI-related evaluations.

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