SMAIO has obtained FDA 510 (k) registration for the Customs Union rod “K Rod”

Lyon, France – (BUSINESS WIRE) – Regulatory News:

SMAIO ((((Sofware, MWith the machine HaveAdaptive MeImplants Orthopaedics – Euronext Growth Paris ISIN Code: FR0014005I80 / Memonic: ALSMA, Eligible PEA-PME (Paris: ALSMA), specializes in complex spinal surgery with a global offer consisting of software, implantable devices and service associates. The French player, K-rod, a custom-made union rod announced today, has been registered with 510 (k) by the Food and Drug Administration (FDA).

Union rod K rod Thanks to the accurate 3D modeling performed by SMAIO’s KEOPS Balance Analyzer 3D software, it is custom-fitted to the patient’s anatomy. Allows for precise alignment of the spinal column on the rod in relation to the Chiron posterior spinal fusion system. The K-Rod series has been available in Europe since June 2019, and with 510 (k) registration, SMAIO will be able to offer these innovative rods to surgeons in North America for the first time.

SMAIO CEO Philippe ROUSSOULY, comment: “In 2012, SMAIO was the first company in the world to announce surgical spine readjustment planning software that could simulate compensation for pelvic and chest patient imbalances. Existing implantable implants on the market today. With the experience of performing thousands of plans for hundreds of surgeons using most of the devices, SMAIO offers a unique and comprehensive solution that combines i-control results planning, execution and evaluation. K Rod With the acquisition of the 510 (k) for the rod, we are now able to offer the entire solution at our North American center. In fact, this “patient-specific” following last month’s Balance Analyzer 3D software. Rod Technology’s 510 (k) registration and the October 2020 Kheiron Spine Immobilization System will enable accelerated overall i-distribution. US control solution. It is part of an overall strategy to make spinal surgery more efficient, safe and predictable. »»

Future financial news :

  • Annual meeting : June 20, 2022
  • 1 saleser Semester 2022: July 12, 2022 after market closure

About SMAIO (www.smaio.com)

A pioneer in the use of clinical data and images of the spine, SMAIO designs global solutions for spinal surgery professionals. The company recognizes its expertise thanks to KEOPS, the global standard big data management software that lists more than 100,000 patient cases.

SMAIO provides spine surgeons with a complete platform, I-Kontrol, which integrates planning, implantable devices, and related services to enable effective, safe, and sustained treatment of spinal conditions. ..

SMAIO is at the forefront of innovation with the ambition to provide surgeons with advanced surgical assistance solutions that deliver high levels of performance and reproducibility.

Lyon-based SMAIO benefits from the skills of more than 30 highly specialized employees.

For more information, please visit www.smaio.com.

Listed market: Euronext Glow Spari

ISIN: FR0014005I80

mnemonic: ALSMA

warning

This release contains unfactual material that includes, but is not limited to, specific statements about future results and other future events. These statements are based on the current views and assumptions of our management. They incorporate known and unknown risks and uncertainties that can make significant differences in actual results, profitability, and expected events. In addition, SMAIO, its shareholders and their respective affiliates, directors, officers, boards and employees have not verified, expressed or warranted the accuracy of the statistical or forward-looking information contained in this release. Is not … Derived from third-party sources or industry publications. These statistical data and forward-looking information are used in this press release for informational purposes only.

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