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

    ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM

    K Number: K964215 · Decision Dec 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    18
    Review Days
    59

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    Basic Information

    Device Name
    ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
    K Number
    K964215
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smith & Nephew Endoscopy, Inc.
    Date Received
    October 22, 1996
    Decision Date
    December 20, 1996
    Product Code
    HRX
    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
    HRX Arthroscope

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