The Guatemala Ministry of Public Health and Social Assistance has certified CTL Amedica Corporation’s registration for two product lines: the VALEO™ II TL Silicon Nitride Interbody Fusion Devices, and the RAPHAEL™ Pedicle Fixation Platform. This certification will enable CTL Amedica to market these products in Guatemala. It is CTL Amedica’s first product registration certification in Central America.
DALLAS (PRWEB) MARCH 31, 2022
The Guatemala Ministry of Public Health and Social Assistance has certified CTL Amedica Corporation’s registration for two product lines: the VALEO™ II TL Silicon Nitride Interbody Fusion Devices, and the RAPHAEL™ Pedicle Fixation Platform. This certification will enable CTL Amedica to market these products in Guatemala. This announcement marks CTL Amedica’s first product registration certification in Central America, and the company says there is more to come. 
“We’re grateful to the Guatemala Ministry of Public Health and Social Assistance for the opportunity to make this important technology available in Guatemala. At CTL Amedica, we design, develop and manufacture innovative medical devices that are efficient and effective for surgeons, all while keeping patients at the forefront of our minds. Our vision is to continue expanding our global footprint, so our novel and streamlined technologies are more accessible internationally,” said Daniel Chon, CTL Amedica president and CEO.
The VALEO™ II TL, Guatemala certified registration product number PMQ-16124, is a transforaminal lumbar interbody fusion or TLIF device. VALEO™ II TL interbody cages are manufactured from silicon nitride, which demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response. CTL Amedica is the world’s exclusive provider of silicon nitride spine products.
The RAPHAEL™, Guatemala certified registration product number PMQ-16125, is an open pedicle fixation platform. It consists of a wide range of polyaxial screws; dual lead and cortical threading; various rods, connectors and hooks; and efficient locking set screws, together providing rigid fixation in posterior lumbar fusions.
VALEO™ II TL and RAPHEL™ are projected to commercialize in Guatemala immediately.
CTL Amedica is a forward-thinking medical device design, development and manufacturing company. CTL Amedica maintains a Texas-based headquarters and in-house manufacturing facility, along with a Pennsylvania-based R&D Center of Excellence. A leader in the medical device technology and biomaterials space, CTL Amedica provides a full line of cervical, thoracic and lumbar fusion and fixation products. In addition, it is the world’s exclusive provider of silicon nitride spine products. Silicon nitride demonstrates unique bacteriostatic properties, provides superior imaging across all modalities and promotes an enhanced osteogenic response. For more information, visit https://www.ctlamedica.com/.
