Ulrich® SOLIDITY® Vertebral Body Replacement. Catalog #UU041-03-1310

Vendor/Manufacturer: Ulrich Medical USA, Inc.

Product/Product Line: SOLIDITY® Vertebral Body Replacement

Vendor/Manufacturer Catalog #: UU041-03-1310

Global Unique Device (GUD) Primary Device Identifier Number:

00814386022422

Global Unique Device (GUD) Device Description:

End cap, oval, 16x13mm, 10°

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: MQP

FDA Classification Product Code Device Name:

Spinal Vertebral Body Replacement Device

FDA Premarket Submissions: K181921

The Ulrich® SOLIDITY® Vertebral Body Replacement is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Osteotech VBR™