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Nanovis Awarded 510(k) for Nano FortiFix® the First Nanotechnology Enhanced Pedicle Screw System

Today Nanovis announced that it received 510(k) clearance for a bioceramic nanotube surface on its Nano FortiFix Pedicle Screw System.

“Nanovis continues to advance innovative technology platforms to improve patient care. We are very pleased to receive the first FDA clearance for a nanotechnology enhanced pedicle screw system. This technology uniquely offers comparative data in the label assessing the relative performance of both human osteoblasts and human mesenchymal stem cells on our bioceramic nanotube surface against both conventional and micron rough titanium surfaces, with or without an acid etched nanoroughness, and with or without a calcium phosphate coated surface. We are particularly grateful to our scientists and innovative surgeon partners for guiding this technology to the market where it can benefit patients,” says Nanovis CEO, Matt Hedrick.

“Surgeons and distributors have been very complementary of the nanotechnology benefits of our Nano FortiCore interbodies and have requested to pair them with nanotechnology enhanced pedicle screws. We plan to offer a complete portfolio of nanotechnology enhanced pedicle screw systems to include open, percutaneous, midline, and deformity, to give patients the most advanced technology possible,” says Nanovis’ VP of Sales, Jeff Shepherd.

Nanovis is actively expanding distribution for bioceramic nanotube enhanced Nano FortiFix pedicle screws and bioceramic nanotube enhanced Nano FortiCore interbodies.

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