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

    Tahoe Unicondylar Knee System with TiNbN Overcoat

    K Number: K260796 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    2
    Review Days
    22

    Basic Information

    Device Name
    Tahoe Unicondylar Knee System with TiNbN Overcoat
    K Number
    K260796
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
    Date Received
    March 11, 2026
    Decision Date
    April 2, 2026
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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