BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CENTRAFIX EXTERNAL FIXATOR

    K Number: K991732 · Decision May 21, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    1
    Review Days
    —

    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
    CENTRAFIX EXTERNAL FIXATOR
    K Number
    K991732
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Owandar Medical, Ltd.
    Date Received
    May 21, 1999
    Decision Date
    May 21, 1999
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

    Similar 510(k) Clearances

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

    SteriTrak

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anjon Bremer Halo System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DigiFix Sterile Kit

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIP Fix

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Anjon Bremer Halo System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medline ReNewal Reprocessed Stryker External Fixation Devices

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all