VEOS FDA 510(k) clearance

Press release        Ecully, October 19, 2023 – 6 p.m.

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

Spineway Group, a specialist in innovative implants for the treatment of severe spinal conditions, is pleased to announce the recent 510(k) clearance from the US Food and Drug Administration (FDA) for its VEOS Spinal Fixation System.

This clearance, which allows Spineway Group to market its VEOS system in the US, represents a significant achievement for the Group and reinforces its strategic approach to develop its business in the US market. This recognition also demonstrates the Group's commitment to provide innovative solutions to surgeons and to put the well-being of patients first.

Presentation at the NASS Congress in Los Angeles

This innovative medical device is presented at the North American Spine Society (NASS) Congress in Los Angeles until 21 October 2023.

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

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

"We are very proud of this FDA clearance, which enables Spineway Group to take the first step in rolling out its new portfolio in the USA. This approval demonstrates our ability to develop innovative solutions for the treatment of spinal pathologies that perfectly meet the needs of surgeons and patients. » says Stéphane Le Roux, CEO of Spineway.

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

SPINEWAY IS ELIGIBLE FOR PEA-SME (EQUITY SAVINGS PLANS FOR SMES)
Find out all about Spineway at www.spineway.com

This press release has been prepared in both English and French. In case of discrepancies, the French version shall prevail.

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its revenue comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), has received the OSEO Excellence award since 2011 and has won the Deloitte Fast 50 award (2011). Rhône Alpes INPI Patent Innovation award (2013) – INPI Talent award (2015).
ISIN: FR001400BVK2 - ALSPW        

Contacts:

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