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

    CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM

    K Number: K101235 · Decision Oct 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    28
    Applicant Total
    6
    Review Days
    175

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    Basic Information

    Device Name
    CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
    K Number
    K101235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neos Surgery S.L
    Date Received
    May 3, 2010
    Decision Date
    October 25, 2010
    Product Code
    GXR
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXR Cover, Burr Hole

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    Other Clearances by Neos Surgery S.L

    K Number Device Name
    K240137 Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
    K221795 STERN FIX Sternal Stabilization System
    K211613 Stern Fix Sternal Stabilization System
    K160739 Cranial COVER
    K132044 CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM