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

    OsteoCentric Spine MIS Pedicle Fastener System

    K Number: K221332 · Decision Jul 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    11
    Review Days
    80

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    Basic Information

    Device Name
    OsteoCentric Spine MIS Pedicle Fastener System
    K Number
    K221332
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OsteoCentric Technologies
    Date Received
    May 9, 2022
    Decision Date
    July 28, 2022
    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 OsteoCentric Technologies

    K Number Device Name
    K251913 OsteoCentric® UnifiMI® TCS Plating System
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    K230242 OsteoCentric Dental Implant System
    K230226 Integrity-SI® Fusion System
    K230595 OsteoCentric ACL Fixation System
    K230764 OsteoCentric Integrated Hip Fastener System
    K222512 Integrity-SI Fusion System
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    K210754 Cannulated Fasteners and Nuts
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