SACRAMENTO, Calif., March 17 /PRNewswire/ -- CUREXO Technology Corporation, pioneer in medical robotics and world leader in image-directed robotic products for orthopaedic applications, which is focused on marketing its ROBODOC(R) Surgical System, announced today that they received the NSAI (National Standards of Ireland) Certificate of Registration of Quality Management System to I.S. EN ISO 13485:2003.
CUREXO Technology Company has been assessed and deemed to comply with the provisions of the above standard in respect to scope of operations to the design, manufacture, distribution and service of the pre-operative workstation and robotic surgical system and related accessories for revision and/or replacement arthroplasty.
"We are pleased to receive the NSAI certificate which validates that CUREXO's quality system meets European requirements," stated Brent Mittelstadt, President and CEO of CUREXO Technology Corporation. "This regulatory milestone brings us one step closer to further expanding our global marketing strategy by entering emerging markets in countries such as Europe, New Zealand and Australia," Mr. Mittelstadt continued.
About CUREXO Technology Corporation
CUREXO Technology Corporation, develops, manufactures, and markets an image directed surgical robotic system for orthopaedic surgery. The ROBODOC(R) Surgical System includes two components; ORTHODOC(R), a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the ROBODOC(R) Surgical Assistant, a computer-controlled surgical robot utilized for precise cavity and surface preparation for hip and knee replacement surgeries.
The ROBODOC(R) Surgical System has been cleared by the U.S. FDA for Total Hip Arthroplasty procedures; making it the only active robotic system cleared by the FDA for orthopedic surgery. To date the system has been used in over 24,000 surgical procedures worldwide.
ROBODOC(R) , ORTHODOC(R) , and DigiMatch(TM) are registered trademarks of CUREXO Technology Corporation. For more information, visit www.robodoc.com.
About NSAI
For over 50 years, the National Standards Authority of Ireland has been offering a full range of services relating to Management Systems Standards and Certification Services throughout the world. The company specializes in medical device, aerospace and environmental certifications. For more information visit www.NSAIinc.com or call 603-882-4412.
CONTACT: Ms. Sheila Shah, Marketing Communications of CUREXO Technology
Corporation, +1-916-285-9943, ext. 510, press@robodoc.com
Web site: http://www.robodoc.com/