Spineway-VEOS FDA 510(k) Clearance – Ortho Spine News

Spineway receives 510(k) clearance from the FDA
for its VEOS spinal fixation system

Ecully, October 19, 2023- Spineway Group, a specialist in innovative implants for the treatment of serious spinal conditions, is pleased to announce the recent 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VEOS Spinal Fixation System.

This approval, which allows Spineway Group to commercialize its VEOS system in the US, represents a significant achievement for the Group and reinforces its strategic approach to developing its business in the US market. This recognition also demonstrates the Group’s commitment to providing innovative solutions to surgeons and putting patients’ well-being first.

Presentation at the NASS conference in Los Angeles

This innovative medical device will be presented at the North American Spine Society (NASS) Congress in Los Angeles through October 21, 2023.

The VEOS Spinal Fixation System is a complete platform that provides an innovative and versatile solution tailored to the needs of surgeons. The VEOS platform is easy to use, fully modular and optimizes operational excellence in the operating room.

This new offering enables surgeons to perform open, minimally invasive and percutaneous surgery (MIS) to treat a wide range of spine pathologies, from degenerative spine to complex surgery and deformities.

“We are very proud of this FDA approval, which allows Spineway Group to take the first step in the rollout of its new portfolio in the US. This approval demonstrates our ability to develop innovative solutions for the treatment of spine pathologies that perfectly meet the needs of surgeons and patients. » says Stéphane Le Roux, CEO of Spineway.

Next events:
October 18 to 20, 2023: Participation in the NASS Congress – Los Angeles (USA)
November 10, 2023: Extraordinary General Meeting

SPINEWAY ELIGIBLE FOR PEA-SME (Small and Medium Business Equity Savings Plans)
Find out all about Spineway at www.spineway.com

This press release has been drawn up in both English and French. In case of contradictions, the French version shall prevail.

Spineway designs, produces and sells innovative implants and surgical instruments for the treatment of serious spinal conditions.
Spineway has an international network of more than 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specialized in innovation), has received the OSEO Excellence Award since 2011 and the Deloitte Fast 50 Award (2011). Rhône Alpes INPI Patent Innovation Award (2013) – INPI Talent Award (2015).
ISIN: FR001400BVK2 – ALSPW

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