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

    RMC TOTAL KNEE SYSTEM

    K Number: K823837 · Decision Mar 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    13
    Applicant Total
    48
    Review Days
    98

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    Basic Information

    Device Name
    RMC TOTAL KNEE SYSTEM
    K Number
    K823837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3560
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    December 21, 1982
    Decision Date
    March 29, 1983
    Product Code
    MBV
    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
    MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

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    Other Clearances by Richard'S Medical Equip., Inc.

    K Number Device Name
    K830793 PATIENT GUIDED ELBOW & SHOULDER EXERC
    K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP
    K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
    K830154 COLLES FRACTURE FRAME
    K823725 SPECTRON PROTRUSIO CUP
    K823728 SPECTRON POLYETHYLENE ACCTUBULAR COMPON
    Search all 48 clearances from Richard'S Medical Equip., Inc. →