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

    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

    K Number: K202289 · Decision Dec 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    54
    Review Days
    126

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    Basic Information

    Device Name
    ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
    K Number
    K202289
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker GmbH
    Date Received
    August 12, 2020
    Decision Date
    December 16, 2020
    Product Code
    KWS
    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
    KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

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