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510(k) Data Aggregation

    K Number
    K253190
    Device Name
    CORUS-LX Implant
    Manufacturer
    Providence Medical Technology, Inc.
    Date Cleared
    2025-11-20

    (55 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K251885,K230840
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

    CORUS-LX is placed through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct.

    CORUS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA cleared intervertebral body fusion device implanted at the same spinal level(s) and may be used with a pedicle screw and rod system (PSR) implanted at the same spinal level(s) to achieve bilateral posterior stabilization.

    The CORUS-LX is intended to be used as part of bilateral posterior fixation that is achieved either with bilateral placement of CORUS-LX Implants or unilateral placement of the CORUS-LX Implant with PSR on the contralateral side.

    CORUS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care.

    Device Description

    CORUS-LX Implant is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. CORUS-LX LevelOne is a kit that contains CORUS-LX Implant and accessories.

    The devices are placed through a posterior surgical approach and achieve facet fixation by spanning the facet interspace at each level with points of fixation at each end of the construct. The devices are manufactured from medical grade titanium alloy (Ti6Al4V) and supplied sterile for single use only with pre-attached disposable delivery instruments. The implants are fenestrated and to be used with autogenous bone and/or allogenic bone graft. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.

    CORUS® Spinal System is used to access and prepare the site for posterior fusion.

    AI/ML Overview

    N/A

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