Vestech Assists with CE Mark and FDA Clearance

Precision Starter KitVestech has been instrumental in assisting Cryptych Pty Limited to achieve ISO 13485 GMP Certification, CE Marking, TGA approval and now FDA Clearance for Cryptych’s innovative “Precision Screw”. The Precision Screw is used during navigated spine surgery to confirm and document the accuracy of the computerised navigation aids throughout the case. Navigation systems do not warrant they accuracy over multiple spine levels, yet this is just where they are most commonly used. Cryptych’s Precision Screw can be used at every level of surgery to confirm the navigation accuracy and document any deviation so that the surgeon can take the difference into account.

Working with Cryptych’s engineers and quality personnel, Vestech has helped implement the ISO13485 Quality System, apply for CE Marking of the screw, work with the TGA to achieve approval for use in Australia and supervise the FDA submission. Recently Cryptych received notification that they had been granted FDA clearance for the Precision Screw’s use in the USA.

Vestech has also assisted Cryptych is setting up distribution in the USA as well as other countries. In trips to the USA in September of 2015 as well as  January and May of 2016 Vestech assisted in setting up distribution network and an office in Irvine California for distribution of the Precision Screw into the US.


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