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

    Episealer Patellofemoral System

    K Number: K221048 · Decision Dec 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    259

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    Basic Information

    Device Name
    Episealer Patellofemoral System
    K Number
    K221048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Episurf Medical, Inc.
    Date Received
    April 8, 2022
    Decision Date
    December 23, 2022
    Product Code
    KRR
    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
    KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

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