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

    TOWNLEY TOTAL ELBOW SYSTEM

    K Number: K955916 · Decision Aug 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    28
    Applicant Total
    9
    Review Days
    223

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    Basic Information

    Device Name
    TOWNLEY TOTAL ELBOW SYSTEM
    K Number
    K955916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3150
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biologically Oriented Prostheses
    Date Received
    December 29, 1995
    Decision Date
    August 8, 1996
    Product Code
    JDC
    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
    JDC Prosthesis, Elbow, Constrained, Cemented

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    Other Clearances by Biologically Oriented Prostheses

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    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