LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030377
    Device Name
    MODIFICATION TO SYNTHES CERVIFIX SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2003-03-06

    (29 days)

    Product Code
    MNI,KWP
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO SYNTHES CERVIFIX SYSTEM

    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.

    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.

    Device Description

    Synthes CerviFix® consists of rods, plate/rods, hooks, clamps, screws, nuts, transconnectors and transverse bars. The implants are composed of Titanium or Stainless Steel.

    AI/ML Overview

    This document is not about a device that uses AI/ML, nor does it describe any study related to device performance in a way that would require acceptance criteria. The document is a 510(k) summary for the Synthes CerviFix® System, a spinal implant system. It primarily discusses the indications for use and substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information. The concepts of acceptance criteria, device performance studies, test sets, ground truth, expert adjudication, MRMC studies, or training sets are not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1