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

    SPINA SYSTEM

    K Number: K033231 · Decision Sep 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    704

    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
    SPINA SYSTEM
    K Number
    K033231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Medical Corp (Nam)
    Date Received
    October 6, 2003
    Decision Date
    September 9, 2005
    Product Code
    ITH
    Advisory Committee
    Physical Medicine
    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
    ITH Equipment, Traction, Powered

    Similar 510(k) Clearances

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

    True Non-Surgical Spinal Decompression System (DRX9000-SL)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DRX9000C-SL Cervical Spinal Decompression System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    c1Trac

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELTRAC 471

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Modpod

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by North American Medical Corp (Nam)

    K Number Device Name
    K073132 MODEL D DISC FORCE