South Korean medical device maker CG MedTech has received regulatory clearance in Colombia for INNOVERSE, its posterior spinal fixation system, and will bring the product to market through local partner IMPLAMEQ. The company said last Wednesday that Colombia’s National Institute for Food and Drug Surveillance (INVIMA) granted the device Class IIb approval on Sept. 30.
Surgeons use INNOVERSE to stabilize and immobilize the thoracic, lumbar and sacral spine. Indications include spondylolisthesis, traumatic fractures and dislocations, spinal stenosis, spinal deformities, pseudarthrosis and revision of failed fusion procedures. The system’s screws feature a dual-thread design that combines two different thread profiles.
The approval covers both versions of the product: an integrated model, in which the screw and head are a single piece, and a modular model whose components are assembled separately. CG MedTech currently manufactures and sells only the integrated version.
Under its agreement with IMPLAMEQ, the company will handle supply of the system in Colombia, along with product training and academic programs for local surgeons and healthcare staff.
“Once a product is approved, what matters is getting it established in clinical practice, and that takes reliable supply and well-trained physicians,” said CEO Yu Hyun-seung.
He added that CG MedTech will work closely with its partner to meet the needs of Colombian clinicians, with the longer-term aim of building a supply and training network across Latin America.
About CGBIO
CGBIO Co., Ltd.. is a total healthcare provider with a goal of enhancing the quality of life by offering range of innovative solutions for the spectrum of spinal disorders and wound management. Through extensive research activity, CGBIO is a leading manufacturer and distributor of comprehensive portfolio of allograft and synthetic bone grafts, spinal implants, GMP grade growth factors and total wound care solution. CG Bio has state of the art facility with class 100 clean rooms, purified water system fit for human injection and qualified technicians.Website: http://www.cgbio.co.kr
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