FDA Grants Clearance to Two VertiFlex Spine Systems

Spinal Tech

The FDA announced 510(k) clearance of two spine surgery devices from VertiFlex, the Totalis Direct Decompression System and the UniVise Spinous Process Fixation System. The Totalis Direct is a set of surgical instruments for minimally invasive direct lumbar decompressions. It uses both reusable and disposable instruments to remove targeted bone and soft tissue to treat spinal stenosis.

The UniVise implant system is used to provide fixation as an adjunct to lumbar spinal fusion.

More Articles on Devices:

AxioMed Spine Collects $3.6M in Device Development Funding
Stryker Hip Implant Recall to Cost at Least $190M
AxoGen to Present Hand Graft Clinical Results at Hand Surgery Conference



Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers