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

    P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR

    K Number: K930712 · Decision Oct 4, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    22
    Review Days
    235

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    Basic Information

    Device Name
    P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR
    K Number
    K930712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Orthopaedics, Inc.
    Date Received
    February 11, 1993
    Decision Date
    October 4, 1993
    Product Code
    LZO
    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
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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    Other Clearances by Johnson & Johnson Orthopaedics, Inc.

    K Number Device Name
    K931466 PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
    K935452 P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
    K940190 ULTIMA UNIPOLAR MODULAR HEAD
    K933275 P.F.C. CERAMIC HIP HEAD
    K932595 ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR
    K931655 P.F.C. BIPOLAR HIP SYSTEM
    K933867 UNIVERSAL INSET PATELLA
    K935262 P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
    K931189 P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
    K931054 TRICK MODULAR KNEE TIBIAL TRAY-POROUS
    Search all 22 clearances from Johnson & Johnson Orthopaedics, Inc. →