Australia TGA ARTG record

Bone-screw internal spinal fixation system, non-sterile

Australia TGA ARTG Registered Device · Evolution Surgical Pty Ltd · Life Spine · Class IIb · Started July 31, 2019

Good Name: Evolution Surgical Pty Ltd - Bone-screw internal spinal fixation system, non-sterile

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: July 31, 2019
Effective Date: July 31, 2019

Sponsor

Name: Evolution Surgical Pty Ltd

Manufacturer

Name: Life Spine
Country: United States of America
Address: 13951 S Quality Dr, Huntley, Illinois, 60142

Intended purpose

The Life Spine Thoracolumbar Spinal Systems consist of screws, longitudinal rods, cross connectors, hooks and offset connectors intended to provide stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The systems are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

About this record

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 sponsored by Evolution Surgical Pty Ltd, manufactured by Life Spine in United States of America. The device registration started on July 31, 2019.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.