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

    KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD

    K Number: K862057 · Decision Jul 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    76
    Review Days
    42

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    Basic Information

    Device Name
    KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD
    K Number
    K862057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Kirschner Medical Corp.
    Date Received
    May 30, 1986
    Decision Date
    July 11, 1986
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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    Other Clearances by Kirschner Medical Corp.

    K Number Device Name
    K940537 KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
    K936274 KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM
    K942891 SUMMIT TOTAL HIP SYSTEM
    K941486 INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
    K933843 LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED
    K935951 KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
    K935206 KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION
    K934589 KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED
    K934694 KIRSCHNER ZIRCONIA FEMORAL HEAD
    K920188 THREADED PINS
    Search all 76 clearances from Kirschner Medical Corp. →