Certificates

TiTaMED Spinal System

FDA Approval

Our covering letter from FDA for our 510(k). (3 pages)

CE

Our Medical Device Directive 93/42/EEC Class IIb CE certificate issued by SGS UK for our Spinal Implant System and Cervical Cages. (1 certificate)

Quality Management System – Medical Manufacturing

ISO 13485:2003

Our ISO 13485:2003 certificate issued by SGS UK for medical devices and implant manufacturing. (1 certificate)

Quality Management System – General Manufacturing

ISO 9001:2008

Our ISO 9001:2008 certificate issued by SGS UK for general engineering and manufacture. (1 certificate)