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

    Release Laminoplasty Fixation System

    K Number: K153735 · Decision Jan 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    29
    Applicant Total
    9
    Review Days
    24

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    Basic Information

    Device Name
    Release Laminoplasty Fixation System
    K Number
    K153735
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
    Date Received
    December 28, 2015
    Decision Date
    January 21, 2016
    Product Code
    NQW
    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
    NQW Orthosis, Spine, Plate, Laminoplasty, Metal

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