BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CATAMARAN™ SI Joint Fusion System

    K Number: K260477 · Decision Apr 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    130
    Applicant Total
    2
    Review Days
    55

    Basic Information

    Device Name
    CATAMARAN™ SI Joint Fusion System
    K Number
    K260477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tenon Medical
    Date Received
    February 12, 2026
    Decision Date
    April 8, 2026
    Product Code
    OUR
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OUR Sacroiliac Joint Fixation

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