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

    PIPELINE CR PRIMARY KNEE SYSTEM

    K Number: K113122 · Decision Mar 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    910
    Applicant Total
    9
    Review Days
    151

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    Basic Information

    Device Name
    PIPELINE CR PRIMARY KNEE SYSTEM
    K Number
    K113122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pipeline Orthopedics
    Date Received
    October 21, 2011
    Decision Date
    March 20, 2012
    Product Code
    JWH
    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
    JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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    Other Clearances by Pipeline Orthopedics

    K Number Device Name
    K131368 NEO KNEE SYSTEM
    K132046 PIPELINE KNEE SYSTEM
    K130353 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
    K131237 PIPELINE TOTAL HIP SYSTEM
    K123692 PIPELINE KNEE SYSTEM
    K122500 NEO PS KNEE SYSTEM
    K120313 NEO CR KNEE SYSTEM
    K112802 PIPELINE TOTAL HIP SYSTEM