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

    Tornier Humeral Reconstruction System (Tornier HRS)

    K Number: K241609 · Decision Sep 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    189
    Applicant Total
    3
    Review Days
    97

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    Basic Information

    Device Name
    Tornier Humeral Reconstruction System (Tornier HRS)
    K Number
    K241609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Corporation (Tornier, Inc.)
    Date Received
    June 5, 2024
    Decision Date
    September 10, 2024
    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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    Other Clearances by Stryker Corporation (Tornier, Inc.)

    K Number Device Name
    K260102 Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
    K241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)