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

    AMERICANA HIP PROTHESIS

    K Number: K922682 · Decision Mar 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    18
    Review Days
    285

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    Basic Information

    Device Name
    AMERICANA HIP PROTHESIS
    K Number
    K922682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Osteo Technology, Inc.
    Date Received
    June 4, 1992
    Decision Date
    March 16, 1993
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

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    Other Clearances by Osteo Technology, Inc.

    K Number Device Name
    K926156 REPLICA(TM) TOTAL HIP SYSTEM
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    K922869 TOTAL CONDYLAT TYPE KNEE SYSTEM
    K925447 OTI ORTHOPEDIC WIRE SYSTEM
    K926213 MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
    K922861 BIOMETRIC SCREW FIXATION CUP
    K922870 THREE SPIKE CUP
    K925301 OTI ORTHOPEDIC FASTENER SYSTEM
    K922871 UNIFIT FEMORAL STEM
    K922868 THOMPSON TYPE HIP PROTHESIS
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