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

    RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS

    K Number: K901289 · Decision Sep 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1106
    Registration Numbers
    1106
    Same Product Code
    57
    Applicant Total
    7
    Review Days
    192

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
    K Number
    K901289
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Mumtaz I. Malik
    Date Received
    March 20, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LXH), ordered by most recent decision date.

    SX-One MicroKnife

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    IMBIBE NEEDLE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    SELF RETAINING SOFT TISSUE RETRACTOR

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    MICROPERFORATION INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY

    FDA 510(k)
    FDA Class 1 ·Orthopedic
    View all

    Other Clearances by Mumtaz I. Malik

    K Number Device Name
    K901521 OSTEOTOMES OF VARIOUS TYPES
    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)