1. Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance | MDDI Online

    Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance | MDDI Online

    Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine.

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