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

    Additive Orthopaedics Bone Wedge System

    K Number: K153207 · Decision Sep 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    6
    Review Days
    307

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    Basic Information

    Device Name
    Additive Orthopaedics Bone Wedge System
    K Number
    K153207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Additive Orthopaedics, LLC
    Date Received
    November 5, 2015
    Decision Date
    September 7, 2016
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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    Other Clearances by Additive Orthopaedics, LLC

    K Number Device Name
    K211076 Patient Specific Marking Guides
    K180239 Additive Orthopaedics Patient Specific 3D Printed Bone Segments
    K163593 Additive Orthopaedics Bunion System
    K170214 Additive Orthopaedics Locking Lattice Plate
    K160264 Additive Orthopaedics Hammertoe Correction System