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510(k) Data Aggregation

    K Number
    K122074
    Device Name
    IFUSE IMPLANT SYSTEM
    Manufacturer
    SI-BONE, INC.
    Date Cleared
    2012-10-12

    (88 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K080398,K092375,K110838
    Predicate For
    K123850,K131405,K141049,K150017,K150714,K150875,K151718,K152681,K160652
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

    Device Description

    The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30mm to 70mm in 5mm increments with a diameter of 4.0 and 7.0 mm. The device is classified as smooth or threaded metallic bone fixation fasteners as Class II devices pursuant to 21 C.F.R. § 888,3040. The fusion rods are implanted using the same instrumentation previously described in K080398, K092375 and K110838.

    AI/ML Overview

    The provided text states: "No performance testing was required to support the modified labeling that is the subject of the 510(k)."

    Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment is available in the provided document. The submission is based on substantial equivalence to a predicate device.

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