ARTG 287905Bone-screw internal spinal fixation system, non-sterile
ARTG ID: 287905 · E4 Surgical Pty Ltd · Precision Spine Inc · Class IIb · Started April 13, 2017
Good Name: E4 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
- 287905
- Start Date
- April 13, 2017
- Effective Date
- April 13, 2017
- Country
- United States of America
- Address
- 2050 Executive Drive, Pearl, MI, 39208
The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra) in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal 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 287905 and sponsored by E4 Surgical Pty Ltd, manufactured by Precision Spine Inc in United States of America. The device registration started on April 13, 2017.
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