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

    Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

    K Number: K251975 · Decision Sep 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    68

    Basic Information

    Device Name
    Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
    K Number
    K251975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3535
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ignite Orthomotion
    Date Received
    June 26, 2025
    Decision Date
    September 2, 2025
    Product Code
    NJD
    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
    NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

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