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

    COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM

    K Number: K123297 · Decision Nov 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    36
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
    K Number
    K123297
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3670
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufactuting Corp.
    Date Received
    October 22, 2012
    Decision Date
    November 20, 2012
    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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