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

    BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD

    K Number: K953045 · Decision Sep 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    9
    Review Days
    89

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    Basic Information

    Device Name
    BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K Number
    K953045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Biologically Oriented Prostheses
    Date Received
    June 30, 1995
    Decision Date
    September 27, 1995
    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 Biologically Oriented Prostheses

    K Number Device Name
    K002325 WUJIN #3 TIBIAL NAIL
    K992144 BIOPRO RIMMED ACETABULAR COMPOMENT
    K964472 RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
    K962769 HORIZON HIP SYSTEM
    K955916 TOWNLEY TOTAL ELBOW SYSTEM
    K954768 BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
    K952731 TOWNLEY ALL POLY ACETABULAR CUP
    K951356 VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED