BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Universal Tendon Spacer

    K Number: K243477 · Decision Jan 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    Universal Tendon Spacer
    K Number
    K243477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3025
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Askorn Medical
    Date Received
    November 8, 2024
    Decision Date
    January 10, 2025
    Product Code
    HXA
    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
    HXA Prosthesis, Tendon, Passive

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