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510(k) Data Aggregation

    K Number
    K071880
    Device Name
    Optima ZS Transition Screw
    Manufacturer
    ZIMMER SPINE, INC
    Date Cleared
    2007-10-05

    (88 days)

    Product Code
    MNI,KWP,MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Optima ZS Transition Screw

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OPTIMA™ ZS Spinal System is a posterior pedicle screw fixation system indicated for the treatment of severe spondylolisthesis, (Grade 3 and 4), of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

    In addition, The OPTIMA™ ZS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:

    • Degenerative spondylolisthesis with objective evidence of neurological impairment
    • Fracture of the vertebral body
    • Dislocation
    • Scoliosis
    • Kyphosis
    • Spinal tumor
    • Failed previous fusion (pseudoarthrosis).

    When the Zimmer GmbH Dynesys® Spinal System and the OPTIMA™ ZS Spinal System are used on contiguous levels, they must be used with the Zimmer GmbH Zimmer DTO™ are acod on combination implant, and the OPTIMA™ ZS Transition Screw. The indications for use for each level is as specified for each system.

    Device Description

    The OPTIMA™ ZS Transition Screw is a posterior pedicle screw that is used as a transition device when the Zimmer GmbH Dynesys® Spinal System and the OPTIMA ZS Spinal System are used on contiquous levels. The OPTIMA ZS Transition Screw interfaces with the rod section of the Zimmer DTO™ Implant, cord-rod combination implant. The cord portion of the Zimmer DTO™ Implant interfaces with the Dynesys Spinal System.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (OPTIMA™ ZS Transition Screw and OPTIMA™ ZS Spinal System), which focuses on establishing substantial equivalence to predicate devices and outlining the intended use and regulatory classifications.

    Therefore, I cannot generate the requested table and study details based on this input.

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