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Medtronic Sofamor Danek ATLANTIS® Anterior Cervical Plate System. Catalog #7200037

  • Writer: CataBlog
    CataBlog
  • Apr 28, 2024
  • 1 min read

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Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ATLANTIS® Anterior Cervical Plate System

Vendor/Manufacturer Catalog #: 7200037

Global Unique Device (GUD) Primary Device Identifier Number:

00613994625137

Global Unique Device (GUD) Device Description:

PLATE 7200037 ATL VISION ELITE 37.5MM


Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal fixation plate, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).


Category 1: Spine

Category 2: Cervical Plate & Screw Systems

Category 3: Plate

Category 4: One Level


FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: KWQ

FDA Classification Product Code Device Name:

Appliance, Fixation, Spinal Intervertebral Body


FDA Premarket Submissions: K130640 , K063100

The Medtronic Sofamor Danek ATLANTIS® Anterior Cervical Plate System is

SUBSTANTIALLY EQUIVALENT to the following products: 






For more information, please visit us at Infonomics.com

 
 
 

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