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

    OPTI-FIX TOTAL HIP SYSTEM

    K Number: K860635 · Decision Mar 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    71
    Review Days
    22

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    Basic Information

    Device Name
    OPTI-FIX TOTAL HIP SYSTEM
    K Number
    K860635
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Richards Medical Co., Inc.
    Date Received
    February 20, 1986
    Decision Date
    March 14, 1986
    Product Code
    LPH
    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
    LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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    Other Clearances by Richards Medical Co., Inc.

    K Number Device Name
    K896106 ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
    K900628 MODULAR HIP SYSTEM
    K896580 UNI-POLAR HEAD
    K895241 INTRAMEDULLARY HIP SCREW
    K884824 TRICON-M TOTAL KNEE SYSTEM
    K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
    K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
    K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
    K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
    K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
    Search all 71 clearances from Richards Medical Co., Inc. →