ARTG 365230Bone-screw internal spinal fixation system, non-sterile
ARTG ID: 365230 · Evolution Surgical Pty Ltd · Ulrich GmbH & Co KG · Class IIb · Started May 10, 2021
Good Name: Evolution Surgical Pty Ltd - Bone-screw internal spinal fixation system, non-sterile
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 365230
- Start Date
- May 10, 2021
- Effective Date
- May 10, 2021
- Country
- Germany
- Address
- Buchbrunnenweg 12, Ulm, 89081
The ulrich Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, the device is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and failed previous fusion.
Access comprehensive regulatory information for Bone-screw internal spinal fixation system, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 365230 and sponsored by Evolution Surgical Pty Ltd, manufactured by Ulrich GmbH & Co KG in Germany. The device registration started on May 10, 2021.
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