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

    ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM

    K Number: K060990 · Decision Apr 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    33
    Review Days
    16

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    Basic Information

    Device Name
    ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
    K Number
    K060990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endius, Inc.
    Date Received
    April 10, 2006
    Decision Date
    April 26, 2006
    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 Endius, Inc.

    K Number Device Name
    K080258 MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K073510 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
    K073267 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K072840 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
    K070282 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K070367 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
    K061345 MODIFICATION TO ENDIUS ATAVI SYSTEM
    K060683 ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
    K053267 ENDIUS ATAVI SYSTEM
    K041808 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
    Search all 33 clearances from Endius, Inc. →