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

    OTI UNICONDULAR INTERPOSITIONAL SPACER

    K Number: K022779 · Decision Nov 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    21
    Review Days
    90

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    Basic Information

    Device Name
    OTI UNICONDULAR INTERPOSITIONAL SPACER
    K Number
    K022779
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3590
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Osteoimplant Technology, Inc.
    Date Received
    August 22, 2002
    Decision Date
    November 20, 2002
    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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