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

    PIPELINE TOTAL HIP SYSTEM

    K Number: K112802 · Decision Mar 9, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    19
    Applicant Total
    9
    Review Days
    164

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    Basic Information

    Device Name
    PIPELINE TOTAL HIP SYSTEM
    K Number
    K112802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pipeline Orthopedics
    Date Received
    September 27, 2011
    Decision Date
    March 9, 2012
    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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    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
    K113122 PIPELINE CR PRIMARY KNEE SYSTEM