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510(k) Data Aggregation

    K Number
    K110990
    Device Name
    GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
    Date Cleared
    2011-07-25

    (108 days)

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

    GOLD STANDARD ORTHOPEDICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior Cervical Plate System is intended for single use only. The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions.
    Device Description
    The ACPI Anterior Cervical Plate System consists of a variety of anterior cervical spinal bone plates and self-drilling / self-tapping bone screws for fixation of the vertebral body(s) of the cervical spine, using an anterior approach for the development of a cervical spinal fusion (C2-C7), and associated instruments. The bone screws form an interlocked construct on the vertebral bodies. The spinal bone plates include an integrated bone screw locking mechanism consisting of an integrated tab retained by a captive locking screw, covering a portion of the underlying bone screw head to prevent bone screw back-out. The bone screws are self-drilling / self-tapping, in various diameters and lengths, and are available in variable angle and fixed angle configurations. All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system was designed to be compatible with common surgical instruments available in operating rooms equipped for spine surgery. The device specific instruments are considered to be Class II. The instruments are medical grade stainless steel, some have silicone rubber handles, and they are provided non-sterile. Stainless steel and titanium implant components must not be used together in a construct.
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    K Number
    K071274
    Device Name
    GSO GS1 SPACER
    Date Cleared
    2007-08-24

    (109 days)

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

    GOLD STANDARD ORTHOPEDICS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The GSO GS1 Spacer is intended for use in the thoracolumbar spine (i.e., T1 - L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GS1 Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The GS1 Spacer is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. Supplemental internal fixation is required to properly utilize this system.
    Device Description
    The GSO GS1 Spacer is a slightly curved, hollow spacer with pyramidal teeth on the superior and inferior ends to resist expulsion. The device contains openings to allow the surgeon to pack the device with bone graft (autograft or allograft) prior to insertion. Openings in the anterior-posterior direction permit bone growth through the device. The GSO GS1 Spacer is intended for use with supplemental internal fixation. The GSO GS1 Spacer is fabricated from medical grade titanium alloy.
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