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510(k) Data Aggregation

    K Number
    K222473
    Device Name
    EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods
    Date Cleared
    2022-10-13

    (58 days)

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

    Medos-International, SARL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EXPEDIUM Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System is intended for noncervical pedicle fixation for the following indications: 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, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pediativ patients, the EXPEDIUM Spine System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The EXPEDIUM VERSE Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM VERSE Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients. the EXPEDIUM VERSE Spine System metallic implants are indicated as an adjunct to freat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM VERSE Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis. fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM VERSE Spine System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.
    Device Description
    The EXPEDIUM Spine System and the EXPEDIUM VERSE Spine System consists of metallic implants intended to provide immobilization and stabilization of spinal segments. The EXPEDIUM Spine System and the EXPEDIUM VERSE Spine System also consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, set screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers.
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