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    K Number
    K023675
    Device Name
    SYNTHES CERVIFIX/ AXON
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2002-11-26

    (25 days)

    Product Code
    KWP
    Regulation Number
    888.3050
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES CERVIFIX/ AXON

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

    The CerviFix® System is indicated for the following:

    • DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
    • Spondylolisthesis
    • Spinal stenosis
    • Fracture/dislocation
    • Atlantoaxial fracture with instability
    • Occipitocervical dislocation
    • Revision of previous cervical spine surgery
    • Tumors

    When used to treat these cervical and occipitocervical conditions, these screws are limited to occipital fixation only.

    Hooks and Rods
    The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

    Rods, Clamps, Screws and Nuts
    The rods, clamps, screws and nuts are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).

    The use of these screws (3.5 mm, 4.0 mm cancellous and 3.5 mm, 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

    Device Description

    Synthes CerviFix® consists of rods, plate/rods, hooks, clamps, screws, nuts and transconnectors. The implants are composed of Titanium or titanium alloy.
    The Synthes CerviFix™ System can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm parallel connectors from that system, and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks, 4.2 mm screws, and the 5.0 mm/ 6.0 mm parallel connector.

    AI/ML Overview

    I am sorry, but the provided text describes a medical device (Synthes CerviFix® System and its accessories) and its indications for use, along with FDA regulatory information (510(k) premarket notification).

    However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to a study proving the device meets acceptance criteria. It is purely a description of the device and its regulatory clearance process.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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