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Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA Cervical VBR -

Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement, made from Invibio Biomaterial's PEEK-OPTIMA™ Hydroxyapatite-Enhanced polymer. The device comes in two footprints and allows for fine adjustments of height and lordosis using spacers and endplates. A hollow center and holes accommodate autograft or allograft, and the device includes anti-migration features. Hydroxyapatite is fully integrated into the polymer matrix, as opposed to being simply coated. The enhanced biomaterial offers the same clinical advantages of PEEK OPTIMA Natural, including a modulus similar to that of cortical bone. (Invibio Biomaterials, 9/24/19)