Polymeric spinal fusion cage, non-sterile

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Classe:

Class IIb

Prodotto da:

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

Area terapeutica:

60762 - Polymeric spinal fusion cage, non-sterile

Indicazioni terapeutiche:

The system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. The system is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2017-02-24