Bone-screw internal spinal fixation system, non-sterile

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

E4 Surgical Pty Ltd

classe:

Class IIb

Fabriqué par:

Precision Spine Inc 2050 Executive Drive, Pearl, MI, 39208 United States Of America

Domaine thérapeutique:

61325 - Bone-screw internal spinal fixation system, non-sterile

indications thérapeutiques:

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.

Statut de autorisation:

A

Date de l'autorisation:

2017-04-13