BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PYRENEES Cervical Plate System Trays

    Reg #: 3004774118 · FEI: 3008599177 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    K2M, INC.
    Registration Number
    3004774118
    FEI Number
    3008599177
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Hope Pkwy SE
    City
    Leesburg
    State
    VA
    ZIP
    20175
    Country
    US

    Owner / Operator

    Firm Name
    VB Spine, LLC
    Operator Number
    10093189
    Address
    505 Park Avenue, 14th Floor
    City
    New York
    State
    NY
    Postal Code
    10022
    Country
    US
    Correspondent
    Christopher Tortora

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM

    Proprietary Names

    PYRENEES Cervical Plate System Trays DENALI Spinal System Trays Cascadia Interbody System ALEUTIAN Interbody Systems Trays EVEREST Spinal System Trays CAYMAN Plate System Trays CAPRI Corpectomy Cage System Trays YUKON OCT Spinal System Trays Navigated Spine Instruments Trays CHESAPEAKE Stabilization System Trays OZARK Cervical Plate System Trays RAVINE Access System Trays CASPIAN Spinal System Trays MESA Spinal System Trays NAPA Access System CANYON Retractor Systems Trays SAHARA Stabilization System Trays

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device