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

    KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM

    K Number: K882241 · Decision Jun 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    76
    Review Days
    33

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    Basic Information

    Device Name
    KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
    K Number
    K882241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Kirschner Medical Corp.
    Date Received
    May 27, 1988
    Decision Date
    June 29, 1988
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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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. →