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

    Streamline OCT Occipito-Cervico-Thoracic System

    K Number: K150254 · Decision Apr 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    9
    Review Days
    84

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    Basic Information

    Device Name
    Streamline OCT Occipito-Cervico-Thoracic System
    K Number
    K150254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    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
    February 3, 2015
    Decision Date
    April 28, 2015
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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    Other Clearances by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

    K Number Device Name
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    K192800 Streamline TL Spinal Fixation System
    K183060 CervAlign™ Anterior Cervical Plate System
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