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510(k) Data Aggregation

    K Number
    K970599
    Device Name
    TOWNLEY PEDICLE SCREW PLATING SYSTEM
    Manufacturer
    DANEK MEDICAL, INC.
    Date Cleared
    1998-03-20

    (395 days)

    Product Code
    MNI,KWP,MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® Plate is positioned over the pedicles. TOWNLEY Pedicle screws are then inserted through the DYNA-LOK plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure.

    This system is indicated for the treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:

    A. Trauma, including spinal fractures and/or dislocations.
    B. Spondylolisthesis.
    C. Spondylolysis.
    D. Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity.
    E. Degenerative disc disease and/or degenerative diseases which include:
    (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
    (b) degenerative disease of the facets with instability.

    Device Description

    This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Screw lengths range from 0.5 to 2.5 inch. Both cortical and cancellous screw threads are available. The stainless steel DYNA-LOK® Plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. All components are fabricated from medical grade stainless steel (ASTM F-138 or its ISO equivalent).

    AI/ML Overview

    The provided text is a 510(k) Pre-market Notification for the TOWNLEY Pedicle Screw Plating System from 1997. This document focuses on establishing substantial equivalence to a predicate device and defining the indications for use. It does not contain any information about acceptance criteria, device performance metrics, or the results of a study (clinical or otherwise) that would "prove" the device meets such criteria.

    Therefore, I cannot provide the requested information. The document is strictly about regulatory clearance based on substantial equivalence, not a performance study report.

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