Surgalign Holdings receives FDA approval for its Cortera Spinal Fixation System, the company's new posterior fixation platform; system developed to work with evolving techniques, technology and enables adoption of HOLO Portal surgical guidance system

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August 31, 2022 (press release) –

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Surgalign Receives US FDA 510(k) Clearance For Cortera Spinal Fixation System

  • 26 Aug 2022
  • United States
  • Orthopaedics

Surgalign Holdings has received the FDA 510(k) clearance for the Cortera Spinal Fixation System. The device is the company's new posterior fixation platform.

The Cortera system is a 5.5/6.0mm rod pedicle screw system that has open and MIS modules. It has a screw design that helps to maintain a comparatively low profile and a newly designed locking mechanism. It has been developed to maximise adoption in the current spine market and for the future of evolving techniques and technology. The system enables the adoption of the HOLO Portal surgical guidance system by providing surgeons and hospitals with two state-of-the-art technologies to perform spinal fusion procedures.

The HOLO Portal surgical guidance system is used to create better user experience for pedicle screw navigation. Additional implants and instruments are intended to add to the Cortera system over the next three to four years to expand applications of the system into a majority of posterior fixation spinal procedures. The limited market release of the device is expected to positively contribute to Q422 results.

This report from Fitch Solutions Country Risk & Industry Research is a product of Fitch Solutions Group Ltd, UK Company registration number 08789939 ('FSG'). FSG is an affiliate of Fitch Ratings Inc. ('Fitch Ratings'). FSG is solely responsible for the content of this report, without any input from Fitch Ratings.
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