Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement, made from Invibio Biomaterial’s PEEK-OPTIMAâ„¢ 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.
This is Omnia’s second 510(k) clearance for the device, following an earlier indication for use in the thoracolumbar spine.
Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement, made from Invibio Biomaterial's PEEK-OPTIMAâ„¢ 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...
Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement, made from Invibio Biomaterial’s PEEK-OPTIMAâ„¢ 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.
This is Omnia’s second 510(k) clearance for the device, following an earlier indication for use in the thoracolumbar spine.
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