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Globus Medical PLYMOUTH Thoracolumbar Plate System. Catalog #1105.1008

  • Writer: CataBlog
    CataBlog
  • May 29, 2022
  • 1 min read

Updated: Apr 30, 2024


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Vendor/Manufacturer: Globus Medical

Vendor/Manufacturer Catalog #: 1105.1008

Global Unique Device (GUD) Primary Device Identifier Number: 00889095027952

Global Unique Device (GUD) Device Description:

PLYMOUTH Thoracolumbar Plate, 14mm


Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Trans-facet-screw internal spinal fixation system, sterile

Global Medical Device Nomenclature (GMDN) Definition:

A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.


Category 1: Spine

Category 2: Thoracolumbar Plate and Screw System

Category 3: Plate


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 Submission: K120092 , K181846


The Globus Medical PLYMOUTH Thoracolumbar Plate System is

SUBSTANTIALLY EQUIVALENT to the following products:






For more information, please visit us at Infonomics.com

 
 
 

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