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

    Choice Spine Hawkeye Vertebral Body Replacement (VBR) System

    K Number: K183588 · Decision Feb 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    276
    Applicant Total
    4
    Review Days
    63

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
    K Number
    K183588
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3060
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Choicespine
    Date Received
    December 21, 2018
    Decision Date
    February 22, 2019
    Product Code
    MQP
    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
    MQP Spinal Vertebral Body Replacement Device

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQP), ordered by most recent decision date.

    VyBrate™ VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Vertiwedge® Intraosseous System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KONG®-TL VBR System and KONG® C VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DOMINION Expandable Corpectomy System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VerteLoc Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ascend VBR System, Ascend NanoTec VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Choicespine

    K Number Device Name
    K171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
    K171456 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
    K132049 THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS