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PRESS RELEASE - Omnia Medical: First PEEK-OPTIMA HA Enhanced Vertebral Body Replacement System to enter US-market

By JALEX Medical
December 08, 2017 Category: Press Releases, News

US FDA 510(k) clearance paves the way for an innovative orthopaedic product that offers the potential to improve bone apposition and, as a consequence, patient outcomes.1-3 Thornton Cleveleys, United Kingdom, December 7, 2017 Omnia Medical VBR has been granted the first US FDA 510(k) clearance for a vertebral body replacement (VBR) system manufactured from PEEK-OPTIMA HA Enhanced polymer, from Invibio Biomaterial Solutions, for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body. This advancement was the result of a three-way collaboration: orthopedic implant company Omnia Medical partnered with JALEX Medical on product development and regulatory activities and with Invibio Biomaterial Solutions, who pioneered medical PEEK. Robert Gewirtz, MD- Neurosurgeon, Columbus, Ohio, comments on the innovative orthopedic product: Omnia Medical VBR is an intuitive device that is easy for the surgeon to use, and the benefits of hydroxyapatite incorporated

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