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

    TIDAL Fusion Cage System

    K Number: K242356 · Decision Mar 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    228

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    Basic Information

    Device Name
    TIDAL Fusion Cage System
    K Number
    K242356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Restor3D, Inc.
    Date Received
    August 8, 2024
    Decision Date
    March 24, 2025
    Product Code
    SAI
    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
    SAI Ankle Fusion Cage

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