BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Drill Bit

    Reg #: 3004774118 · FEI: 3008599177 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Drill Bit General Instruments Orthopaedic Manual Instrumentation UniVise Terra Nova, Ravine, Serengeti, VCR, Cricket Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini ORTHOPEDIC MANUAL NAPA Access System Cascadia Interbody System Screw Insertion Sleeve

    Establishment Types

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