icotec ag Announces FDA 510(k) Clearance for VADER® Pedicle System Navigated Instruments, Advancing Precision and Safety in Spinal Implantation

ALTSTAETTEN, Switzerland, July 27, 2023 /PRNewswire/ — icotec, a leading medical device manufacturer specializing in BlackArmor® Carbon/PEEK spinal implants, is pleased to announce the receipt of FDA 510(k) clearance for its VADER® Pedicle System Navigated Instruments. This achievement represents a significant step forward in enhancing surgical precision and safety for spine surgeons using our innovative BlackArmor® Carbon/PEEK implants.

As part of our commitment to providing the safest and most seamless surgical experience, icotec has integrated assistive technologies, such as navigation, into our instrumentation. This combination of standard surgical techniques with advanced navigation capabilities ensures that our procedures align with industry standards and deliver optimal outcomes for our patients.

The newly cleared Navigation set includes a comprehensive range of instruments, for both Open and MIS surgery. This expanded portfolio empowers surgeons with enhanced precision and accuracy during procedures, enabling them to achieve superior outcomes for their patients.

“Receiving FDA 510(k) clearance for our navigated instrumentation is a significant achievement for icotec,” said Roger Stadler, CEO at icotec, “We are proud to offer our surgeons the tools they need to perform these procedures with the utmost precision and confidence. This clearance opens new opportunities for growth and reaffirms our position as the leader in Carbon/PEEK implants and our commitment to keeping a standard surgical technique.”

icotec would like to extend its gratitude to the entire team for their dedication and hard work in making this successful upcoming launch possible. Their commitment to innovation and patient-centered care has been instrumental in achieving this milestone.

For more information on icotec’s spinal implant solutions, please visit our website at www.icotec-medical.com.

About icotec

icotec is a leading medical device manufacturer founded in 1999 and dedicated to advancing the field of spinal implantation. With a strong focus on Carbon/PEEK implants, icotec combines cutting-edge technologies and industry expertise to deliver innovative and reliable solutions for spine surgeons and their patients. With a track record of clinical success and a commitment to continuous innovation, icotec is poised to shape the future of spinal surgery.

SOURCE Icotec Medical