BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

    K Number: K210122 · Decision Aug 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    219
    Applicant Total
    20
    Review Days
    220

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
    K Number
    K210122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteonic Co., Ltd.
    Date Received
    January 19, 2021
    Decision Date
    August 27, 2021
    Product Code
    MAI
    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
    MAI Fastener, Fixation, Biodegradable, Soft Tissue

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MAI), ordered by most recent decision date.

    Arthrex Bioabsorbable PushLock Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SF Push-in Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIOfiber® Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Biosteon® Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BioBrace® Extra-Articular Ligament Augmentation Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSSIOfiber® Interference Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Osteonic Co., Ltd.

    K Number Device Name
    K254182 Aster
    K243469 SIGNEX
    K243467 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
    K243470 Fix2Lock (PEEK Self Punching)
    K230546 SIGNEX
    K233659 Suture Wing
    K231322 Fix2Lock(PEEK Self Punching)
    K231326 Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
    K210360 Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
    K211992 Ortho MI System
    Search all 20 clearances from Osteonic Co., Ltd. →