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

    Corin TaperFit Hip Stem

    K Number: K153725 · Decision Mar 25, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    21
    Review Days
    88

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    Basic Information

    Device Name
    Corin TaperFit Hip Stem
    K Number
    K153725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corin U.S.A. Limited
    Date Received
    December 28, 2015
    Decision Date
    March 25, 2016
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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    Other Clearances by Corin U.S.A. Limited

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    K241570 Unity Total Knee System
    K240875 Unity Knee PS-C Tibial Insert
    K231172 ApolloKnee
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    K191831 MobiliT Cup
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