The Information is for use only in countries with applicable health authority product registrations. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes.
Federal Law (USA) restricts these devices to sale by or on the order of a physician. Refer to Relign Tricera System Instructions Manual for complete Indications for Use, Contraindications, Warnings and Benefit/Risk Determination.
Summary of Safety and Effectiveness Data on file at www.FDA.gov:
1. Relign System Relign Corporation 510(k) NO: K162770(Traditional)