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510(k) Data Aggregation

    K Number
    K252166

    Validate with FDA (Live)

    Device Name
    RIB LINK™ Fixation System
    Manufacturer
    Globus Medical, Inc.
    Date Cleared
    2026-02-26

    (231 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 120
    Reference & Predicate Devices
    K113395,K182375,K163361,K190409,K212608
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The RIB LINK™ Fixation System is indicated for use in the stabilization, fixation, and reconstruction of rib fractures, fusions, osteotomies, resections, including spanning gaps and/or defects, and chest wall deformities including rib hump deformity. These implants are indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation.

    Device Description

    The RIB LINK™ Fixation System includes a variety of plates, rods, and screws intended for use in rib fixation and stabilization applications. The implants are available in various sizes and styles and can be assembled in multiple construct configurations to accommodate varying patient anatomy. The constructs can be surgically positioned across the external surface of the ribs. RIB LINK™ implants are manufactured from titanium alloy as specified in ASTM F136.

    AI/ML Overview

    N/A

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