#TSP TruSpine PLC – Further re: FDA Update October 12, 2023 – Posted in: TruSpine Plc (TSP) – Tags: abuse, device, documentation, fda, market, medical, screwless, stabilisation

TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its pioneering “screwless,” spinal (vertebral) stabilisation systems announces that, further to the announcement on 3 October 2023, the Company has submitted additional documentation and provided further clarification in regard to the questions raised by the U.S. Food and Drug Administration (“FDA”) relating to the Company’s FDA 510(k) application.

TruSpine CEO Laurence Strauss commented: “We are pleased the US FDA have responded promptly regarding our 510(k) application for Cervi-LOK. Our board have sought to clarify the matters raised and responded promptly with the required documentation. The Board believes the information provided should assist the FDA and help them to complete their technical review. I look forward to reporting back with further progress.”

This announcement contains inside information for the purposes of the UK Market Abuse Regulation, and the Directors of the Company are responsible for the release of this announcement.

Enquiries: