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

    Avitus(r) Bone Harvester

    K Number: K210631 · Decision Mar 31, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    Avitus(r) Bone Harvester
    K Number
    K210631
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avitus Orthopaedics, Inc.
    Date Received
    March 3, 2021
    Decision Date
    March 31, 2021
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    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
    KNW Instrument, Biopsy

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    Other Clearances by Avitus Orthopaedics, Inc.

    K Number Device Name
    K231456 Avitus® DragonWing Large Volume Autograft Delivery System
    K230492 Avitus® Precision Autograft Delivery System
    K170539 Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
    K152474 Avitus Bone Harvester