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

    Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System

    K Number: K162153 · Decision Jul 14, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    7
    Review Days
    346

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    Basic Information

    Device Name
    Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
    K Number
    K162153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascension Orthopedics
    Date Received
    August 2, 2016
    Decision Date
    July 14, 2017
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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