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

    Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

    K Number: K200328 · Decision Mar 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    19
    Applicant Total
    15
    Review Days
    30

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    Basic Information

    Device Name
    Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
    K Number
    K200328
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kyocera Medical Technologies, Inc.
    Date Received
    February 10, 2020
    Decision Date
    March 11, 2020
    Product Code
    OQG
    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
    OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

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