Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K053623
    Device Name
    NFIX FUSION SYSTEM
    Manufacturer
    N-SPINE, INC.
    Date Cleared
    2006-07-12

    (196 days)

    Product Code
    MNH
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    N-SPINE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NFix Fusion System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the NFix Fusion System is intended for skeletally mature with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
    Device Description
    The NFix Fusion System consists of four or more pedicle screws and two NFix solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The NFix solid rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Crosslinks can be used if additional stabilization is necessary.
    Ask a Question

    Page 1 of 1