Icotec AG Attains FDA 510(k) Clearance for VADER® Pedicle System Navigated Instruments, Enhancing Precision and Safety in Spinal Implantation

Friday, July 28, 2023

icotec, a well-known medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is excited to announce that it has received FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This clearance represents a major step forward in improving surgical precision and safety for spine surgeons using icotec's innovative BlackArmor® Carbon/PEEK implants.

As part of their commitment to providing the safest and most seamless surgical experience, icotec has integrated advanced technologies, such as navigation, into their instrumentation. By combining standard surgical techniques with state-of-the-art navigation capabilities, their procedures align with industry standards and deliver optimal outcomes for patients.

The newly cleared Navigation set includes a comprehensive range of instruments, suitable for both Open and Minimally Invasive Surgery (MIS). This expanded portfolio empowers surgeons with enhanced precision and accuracy during procedures, leading to superior outcomes for their patients.



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