VersaLink? Fixation System with Polyaxial Pedicle Screws - Fixation system, internal, spinal, bone screw

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Beszerezhető a:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Osztály:

Class IIb

Gyártó:

Premia Spine Ltd 7 Giborey Israel Street, Netanya, Ramat Poleg, 4250407 Israel

Terápiás terület:

43257 - Fixation system, internal, spinal, bone screw

Terápiás javallatok:

The VersaLink? Fixation System is intended to treat L1 to S1 spinal lumbar pathologies that require decompression of the spinal canal and restoration of the segment stability by an instrumented fixation performed in a posterior surgical approach. The system is intended for single or multi level pathologies, indicated for spinal fusion procedures in skeletally mature patients that require stabilization for pathologies including degenerative disc disease (DDD), disc herniation, lumbar spinal stenosis and, spondylolisthesis (up to grade 1). The system is intended to be used with or without anterior interbody support and autogenous bone graft (placed from a posterior approach only). The system consists of a ring nut, upright rod, ring set screw, crossbar rod and polyaxial pedicle screws. The VersaLink? Fixation System is to be used only with TOPS? System's Pedicle Screws supplied by Premia Spine.

Engedélyezési státusz:

A

Engedély dátuma:

2016-01-14