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

    Identity Revision Humeral Stems

    K Number: K251098 · Decision Aug 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    36
    Applicant Total
    376
    Review Days
    123

    Basic Information

    Device Name
    Identity Revision Humeral Stems
    K Number
    K251098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3670
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    April 10, 2025
    Decision Date
    August 11, 2025
    Product Code
    MBF
    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
    MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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