News & Events

OrthoXel Secures FDA 510(k) Clearance & CE Mark Approval for Apex Tibial Nailing System

OrthoXel, an innovative new orthopaedic trauma company, pioneering the use of enhanced fracture fixation to stimulate callus formation with the goal to reduce healing time, is delighted to announce that FDA 510k clearance and European CE mark approval have been granted for their Apex Tibial Nailing System. These approvals allow commercialization of the system in the US and EU markets.  The Apex Tibial Nailing system offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care with a simple and intuitive surgical procedure.

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