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

    PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM

    K Number: K930771 · Decision Nov 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    60
    Review Days
    652

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    Basic Information

    Device Name
    PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
    K Number
    K930771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Orthomet, Inc.
    Date Received
    February 16, 1993
    Decision Date
    November 30, 1994
    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 Orthomet, Inc.

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    K944752 ORTHOMET RESURFACING FEMORAL COMPONENT
    K926334 AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
    K932677 AXIOM TOTAL KNEE SYSTEM
    K931678 ORTHOMET LHMC FEMORAL STEM
    K931333 ORTHOMET ACETABULAR CUP SYSTEM
    K923243 PERFECTA TOTAL HIP SYSTEM
    K925536 HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
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