TruSpine Technologies PLC - London Gatwick Airport-based medical device company - Submits additional documentation and further clarification to the US Food & Drug Administration regarding its 510(k) application for Cervi-LOK. Earlier this month, the FDA confirmed it had completed the technical screening of TruSpine's 510(k) submission, which was submitted in late July, but sought further clarification on certain matters. The application was placed on technical screening hold "until such time the relevant information requested has been provided to the FDA", adding that the submission could remain on hold until March 25 next year.

Chief Executive Officer Laurence Staruss 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."

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By Sabrina Penty, Alliance News reporter

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