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

    canturio® se (Canturio Smart Extension)

    K Number: K234056 · Decision Apr 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    124

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    Basic Information

    Device Name
    canturio® se (Canturio Smart Extension)
    K Number
    K234056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3600
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canary Medical USA, LLC
    Date Received
    December 22, 2023
    Decision Date
    April 24, 2024
    Product Code
    QPP
    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
    QPP Implantable Post-Surgical Kinematic Measurement Knee Device

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    Other Clearances by Canary Medical USA, LLC

    K Number Device Name
    K223803 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
    K220413 Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System