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

    UNICONDYLAR INTERPOSITIONAL SPACER

    K Number: K003269 · Decision Jan 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    45
    Review Days
    78

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    Basic Information

    Device Name
    UNICONDYLAR INTERPOSITIONAL SPACER
    K Number
    K003269
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3590
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Orthopedics, Inc.
    Date Received
    October 18, 2000
    Decision Date
    January 4, 2001
    Product Code
    HSH
    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
    HSH Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)

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