icotec has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its VADER Pedicle System Navigated Instruments.
icotec stated that this approval marks a significant advancement in improving surgical precision and safety for spine surgeons leveraging BlackArmor Carbon/PEEK implants.
The new navigation set consists of a comprehensive range of instruments for both open and minimally invasive surgery (MIS) surgery.
icotec has incorporated assistive technologies into its instrumentation as part of its commitment to deliver a safe and seamless surgical experience.
CEO Roger Stadler said: “Receiving FDA 510(k) clearance for our navigated instrumentation is a significant achievement for 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.”
In January this year, icotec received 510(k) clearance from the FDA for its extended VADER Pedicle System.
The approval was provided for the VADER Pedicle System inclusive of Ø 4.5mm pedicle screws along with extended long Carbon/PEEK rods made from BlackArmor.
Established in 1999, icotec is a Switzerland-based medical device manufacturer engaged in the development of spinal implants.
The company leverages advanced technologies and industry expertise for producing Carbon/PEEK implants.
