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510(k) Data Aggregation

    K Number
    K130066
    Device Name
    SPECTRUM SPINE SPINOUS PROCESS DEVICE
    Date Cleared
    2013-11-12

    (306 days)

    Product Code
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPECTRUM SPINE IP HOLDINGS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.
    Device Description
    The Spectrum Spine Spinous Process Device is a permanent implant device with plates and rods made from Titanium Alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67 and cages made from polyetheretherketone (Zeniva PEEK 500 per ASTM F2026-10, PEEK Polymer for surgical implant applications). It is a posterior, non-pedicle supplemental fixation device. The device provides plates, cages and connecting rods of various shapes and sizes to provide supplemental stabilization of the spinous process to support fusion.
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