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

    PRIME CEMENTED HIP SYSTEM

    K Number: K940328 · Decision Apr 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    8
    Review Days
    438

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    Basic Information

    Device Name
    PRIME CEMENTED HIP SYSTEM
    K Number
    K940328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Orthopaedic Innovations, Inc.
    Date Received
    January 24, 1994
    Decision Date
    April 7, 1995
    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 Orthopaedic Innovations, Inc.

    K Number Device Name
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    K962646 PRIME MODULAR ENDO HEAD
    K960014 PRACTIFIX EXTERNAL FIXATION SYSTEM
    K955620 PRIME CEMENTED CALCAR FEMORAL STEMS
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    K953033 PRIME CEMENTED SMALL FEMORAL STEM