BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant

    K Number: K230891 · Decision Dec 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    263
    Registration Numbers
    263
    Same Product Code
    564
    Applicant Total
    5
    Review Days
    272

    Basic Information

    Device Name
    SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
    K Number
    K230891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Healthium Medtech Limited
    Date Received
    March 31, 2023
    Decision Date
    December 28, 2023
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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    Other Clearances by Healthium Medtech Limited

    K Number Device Name
    K231033 CEPTRE® Knotted UHMWPE Suture PEEK Anchor
    K232886 INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
    K231404 T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
    K223889 Stativ® Knotted UHMWPE Suture Anchor