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

    HORIZON HIP SYSTEM

    K Number: K962769 · Decision Oct 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    560
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    HORIZON HIP SYSTEM
    K Number
    K962769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3358
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biologically Oriented Prostheses
    Date Received
    July 16, 1996
    Decision Date
    October 3, 1996
    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 Biologically Oriented Prostheses

    K Number Device Name
    K002325 WUJIN #3 TIBIAL NAIL
    K992144 BIOPRO RIMMED ACETABULAR COMPOMENT
    K964472 RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
    K955916 TOWNLEY TOTAL ELBOW SYSTEM
    K954768 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K952731 TOWNLEY ALL POLY ACETABULAR CUP
    K953045 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K951356 VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED