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

    DEPUY LPS PROXIMAL TIBIAL COMPONENT

    K Number: K062301 · Decision Oct 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    207
    Review Days
    66

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    Basic Information

    Device Name
    DEPUY LPS PROXIMAL TIBIAL COMPONENT
    K Number
    K062301
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DePuy Orthopaedics, Inc.
    Date Received
    August 8, 2006
    Decision Date
    October 13, 2006
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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    Other Clearances by DePuy Orthopaedics, Inc.

    K Number Device Name
    K252887 DePuy ATTUNE™ Knee System
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    K213839 DePuy Corail AMT Hip Prosthesis
    K210167 DELTA XTEND Reverse Shoulder System
    K203167 DePuy Corail AMT Hip Prosthesis
    K202472 ACTIS Duofix Hip Prosthesis
    K201347 DePuy ATTUNE™ Total Knee System
    K193540 TRUMATCH Personalized Solutions
    K193398 Summit DuoFix HA Coating
    K192946 DePuy Corail AMT Hip Prosthesis
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