Polymeric spinal fusion cage, non-sterile

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:

L&K Biomed Co Ltd #201 & #202 16-25 Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si, Gyeonggi-do, 17015 Korea - Republic of

Terápiás terület:

60762 - Polymeric spinal fusion cage, non-sterile

Terápiás javallatok:

The system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. The system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Engedélyezési státusz:

A

Engedély dátuma:

2017-02-24