Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062371
    Device Name
    PREVIEW ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    ALPHASPINE, INC.
    Date Cleared
    2006-12-04

    (112 days)

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

    ALPHASPINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PreView™ Anterior Ccrvical Plate System is intended for the treatment of the cervical spine in skeletally mature patients.receiving fusion-by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The PreView™ Anterior Cervical Plate System is intended for use under the following indications: ) · Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Spondylolisthesis - · Trauma (i.e., fracture or dislocation) · Spinal stenosis - · Deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) • Tumor - Pseudoarthrosis - · Failed previous fusion
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1