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510(k) Data Aggregation

    K Number
    K200958
    Device Name
    MODULIF-A Anterior Lumbar Interbody Fusion System
    Date Cleared
    2020-08-28

    (140 days)

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

    Spinal Stability, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MODULIF-A is an interbody fusion device intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal procedure at the involved level(s). The device system is designed for use with supplemental fixation and with autogenous or allograft comprised of cancellous and / or corticocancellous bone graft to facilitate fusion. Patients should have six months of non-operative treatment prior to treatment with an interbody fusion cage. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.
    Device Description
    The Spinal Stability MODULIF-A is a modular interbody fusion cage intended for the treatment of degenerative disc disease in the lumbar spine used to provide structural stability in skeletally mature patients. The MODULIF-A device is composed of two endplates and a central spacer. The device may be implanted as a single construct via an anterior approach. The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches.
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