Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K162693
    Device Name
    VertebraLINK Fusion Platform
    Date Cleared
    2017-03-29

    (183 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    FACETLINK DBA LINKSPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VertebraLINK Fusion Platform is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via posterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
    Device Description
    The VertebraLINK Fusion Platform is a comprehensive suite of generally box shaped devices which can be implanted into the prepared disc space when performing an intervertebral body fusion. The devices are manufactured from Invibio's PEEK Optima LT1 or PEEK Optima HA Enhanced per ASTM F2026. The devices contain a central axial opening for packing of bone graft material as well as teeth on the inferior and superior surfaces to resist expulsion. The platform will be offered in multiple lengths, widths, heights and lordoses to accommodate varying anatomies, pathologies, surgeon preferences, or techniques (i.e., TLIF, PLIF, or Oblique PLIF). Additionally, the device contains radiographic markers made from tantalum per ASTM F560.
    Ask a Question

    Ask a specific question about this device

    K Number
    K160722
    Device Name
    CorticaLINK Spinal Fusion Platform
    Date Cleared
    2016-07-07

    (113 days)

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

    FACETLINK DBA LINKSPINE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients: - degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); - spondylolisthesis; - trauma (i.e., fracture or dislocation); - spinal stenosis; - curvatures (i.e., scoliosis, kyphosis, and/or lordosis); - tumor; - pseudoarthrosis; - and failed previous fusion.
    Device Description
    The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1