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

    Tigon Medical All-Suture Anchors (ASA)

    K Number: K242529 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    7
    Review Days
    116

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    Basic Information

    Device Name
    Tigon Medical All-Suture Anchors (ASA)
    K Number
    K242529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tigon Medical
    Date Received
    August 26, 2024
    Decision Date
    December 20, 2024
    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 Tigon Medical

    K Number Device Name
    K260921 Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
    K252596 Tigon Medical Knotless and Dual Javelin All-Suture Anchors
    K240175 Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
    K220464 Tigon Medical Gryphon Anchor Line
    K211049 Tigon Medical Button System
    K182507 Tigon Medical Tissue Anchors