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510(k) Data Aggregation

    K Number
    K253118

    Validate with FDA (Live)

    Device Name
    Companion Spine DIAM™ Instrumentation
    Manufacturer
    Companion Spine France
    Date Cleared
    2025-12-16

    (83 days)

    Product Code
    QLR
    Regulation Number
    888.4520
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    K253118**
    Trade/Device Name: Companion Spine DIAM™ Instrumentation
    Regulation Number: 21 CFR 888.4520
    Containers, Trays, Cassettes & Other Accessories

    Regulatory Class: II

    Product Codes: QLR, KCT (888.4520

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

    The Companion Spine DIAM™ Instrumentation is indicated for the insertion and positioning of the Companion Spine DIAM™ Spinal Stabilization System devices, or if required, removal of the implantable device.

    Device Description

    The Companion Spine DIAM™ Instrumentation are non-implant devices that consist of device-specific instruments for use in implantation of Companion Spine DIAM™ Spinal Stabilization System devices. These instruments are manual and non-powered surgical tools with implant specific geometry that are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.

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