BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OSTEOTOMES OF VARIOUS TYPES

    K Number: K901521 · Decision Sep 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1106
    Registration Numbers
    1106
    Same Product Code
    57
    Applicant Total
    7
    Review Days
    179

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    Basic Information

    Device Name
    OSTEOTOMES OF VARIOUS TYPES
    K Number
    K901521
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Mumtaz I. Malik
    Date Received
    April 2, 1990
    Decision Date
    September 28, 1990
    Product Code
    LXH
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXH Orthopedic Manual Surgical Instrument

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    Other Clearances by Mumtaz I. Malik

    K Number Device Name
    K901289 RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
    K901511 CHISEL, BONE, SURGICAL
    K901420 VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8
    K893902 4 X 4 STERILE GAUZE SPONGE TRAY
    K890071 STERILE LACERATION TRAY
    K884195 GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)