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

    UCR SPINAL SYSTEM

    K Number: K043232 · Decision Dec 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    UCR SPINAL SYSTEM
    K Number
    K043232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seaspine
    Date Received
    November 22, 2004
    Decision Date
    December 21, 2004
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by Seaspine

    K Number Device Name
    K040130 ANTERIOR LUMBAR BUTTRESS SYSTEM
    K032739 UCR SPINAL SYSTEM
    K032368 SONOMA ANTERIOR CERVICAL PLATE SYSTEM
    K031381 UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS