This article is more than 5 years old. Information may no longer be current.

SpineGuard announces FDA 510(k) clearance of new device for pedicle screw insertion

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

SpineGuard announced it has received FDA 510(k) clearance for its PediGuard Threaded DSG device.

“We are excited by the clearance of our PediGuard Threaded device, which brings a new generation of [dynamic surgical guidance] DSG-enabled probes to the U.S. market, offering spine surgeons the added clinical benefit of reducing surgical steps in fusion surgery,” Stéphane Bette, cofounder, chief technology officer and U.S. general manager of SpineGuard, said in the release. “This clearance allows our network of agents to initiate the commercial phase of this unique value proposition in a $7-billion market that is under price pressure and in tremendous need for differentiation.”

According to the release, the device may be used for either open or minimally invasive approaches for pedicle screw insertion. The device reportedly comes in different designs for surgeons’ preferences and patients’ anatomy.

Reference:

www.spineguard.com