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Medical Devices / Submissions and Approvals

OrthoXel Apex Tibial Nailing System Achieves FDA Clearance and CE Mark

Jan. 19, 2018
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Orthopedic trauma devicemaker OrthoXel, achieved both FDA 510(k) clearance and CE Mark for its Apex Tibial Nailing system.

The system has multiple locking modes, including the standard cross-locking and dynamization locking, to enable surgeons to tailor the fixation to patients’ individual health needs.

The device “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,” the company said.

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