#TSP TruSpine Technologies – FDA Update February 19, 2024 – Posted in: TruSpine Plc (TSP) – Tags: biopharmaceutical, fda, health

TruSpine Technologies Plc, the medical device company focused on the spinal (vertebral) stabilisation market, announces an update on its U.S. Food and Drug Administration (“FDA”) process in relation to its FDA 510(k) application for its Cervi-LOK product.

Further to the announcement on 5 January 2024, the Company confirms it has submitted additional documentation to the FDA in respect of the additional clarifications that the FDA were seeking. In the weeks leading up to the FDA submission, the Company has been in dialogue with FDA representatives in order to ensure all clarifications were discussed and answered to the extent possible. A further announcement will be made in due course.

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.

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