Vendor/Manufacturer: Ulrich Medical USA, Inc.
Product/Product Line: SMALL VBR® Vertebral Body Replacement
Vendor/Manufacturer Catalog #: CS 2250-12-16
Global Unique Device (GUD) Primary Device Identifier Number:
04052536004270
Global Unique Device (GUD) Device Description:
ADD/Small VBR, ø 12 mm, height 16-25 mm, angle 0°
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Vertebral body prosthesis
Global Medical Device Nomenclature (GMDN) Definition:
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
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(s): MQP, PLR
FDA Classification Product Code Device Name:
MQP: Spinal Vertebral Body Replacement Device
PLR: Spinal Vertebral Body Replacement Device - Cervical
The Ulrich® SMALL VBR® Vertebral Body Replacement is
SUBSTANTIALLY EQUIVALENT to the following product(s):
1. Ulrich VBR™
For more information, please visit us at Infonomics.com