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

    SYSTEM III HALO RING

    K Number: K930153 · Decision Aug 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    9
    Review Days
    206

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    Basic Information

    Device Name
    SYSTEM III HALO RING
    K Number
    K930153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jerome Medical
    Date Received
    January 12, 1993
    Decision Date
    August 6, 1993
    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

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    Other Clearances by Jerome Medical

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    K864969 JMS HALO APPLICATION TRAY
    K844490 TRACTION ACCESSORIES
    K822780 CERVICAL BRACE
    K821582 WARM'N FORM SPORTS SUPPORTS