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510(k) Data Aggregation

    K Number
    K133363
    Device Name
    INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
    Manufacturer
    LDR SPINE, USA, INC.
    Date Cleared
    2014-03-07

    (126 days)

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

    LDR SPINE, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: - . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis . - Trauma (fracture or dislocation) . - . Tumor The InterBRIDGE® system is not intended for stand-alone use.
    Device Description
    The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion. The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.
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