BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sizer

    Reg #: 3004893332 · FEI: 3004893332 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    87
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPINAL ELEMENTS, INC.
    Registration Number
    3004893332
    FEI Number
    3004893332
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3115 Melrose Dr Suite 200
    City
    CARLSBAD
    State
    CA
    ZIP
    92010
    Country
    US

    Owner / Operator

    Firm Name
    Spinal Elements
    Operator Number
    9048980
    Address
    3115 Melrose Dr Suite 200
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US
    Correspondent
    Cheryl Allen

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    Sizer Rod Template Wrench Hammer Disc Shaver Broach Caliper Hex Driver Crown Trephine Screw Adjuster Box Chisel Counter Torque Set Screw Starter Compressor Fulcrum Curette Nerve Sheild Suction Tube Probe Rod Bender Ejector Tap Tulip Adjuster Persuader Rongeur Tamp Guide Wire Depth Sounder Tulip Positioner Elevator Osteotome Graft Block Reducer Post Remover Tower Clip Pusher Retainer Stabilizer Handle Compactor Rod Gripper Compressor Packing Block Temporary Fixation Screw Plate Holder Dilator Rod Holder Nerver Root Retractor Access Portal Pin Inserter Inserter Distraction Pin Driver Depth Tool Plate Shaver Spacer Hex Retainer Retractor Disc Cutter Drill Screwdriver Temporary Fixation Pin Funnel Tab Breaker Distractor Cannula Hex Adapter Crow Foot Awl Pedicle Feeler Adaptor Chisel Guide Disc Shaper Plate Bender Trial Distraction Pin Sleeve Lodestar Tab Extender Rasp Cobb Removal Tool Rocker Marquise MIS Channel Tab Cutter Pedicle Marker Dual Stylet Needle

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198