Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K100215
    Device Name
    ARCHIMED REMEDY CERVICAL PLATE
    Manufacturer
    Date Cleared
    2010-04-07

    (72 days)

    Product Code
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARCHIMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The REMEDY™ Cervical Plate System is intended for anterior interbody screw/plate fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Trauma (including fractures), 3) Tumors, 4) Deformity (defined as kyphosis, lordosis, or scoliosis), 5) Pseudarthrosis, and/or 6) Failed previous fusions.
    Device Description
    The Remedy Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The REMEDY Cervical Plate System implant components are made from titanium alloy described by ASTM F136.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1