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October 7, 2009
OrthAlign receives KneeAlign® 510(k) Market Clearance from US Food and Drug Administration
Irvine, CA - October 7, 2009 - OrthAlign, Inc.,
Irvine, CA - October 7, 2009 - OrthAlign, Inc., a privately held medical device company in Orange County, CA, received a 510(k) market clearance letter from the US Food and Drug Administration, confirming that its KneeAlign® disposable computer-assisted surgical ("CAS") navigation system for total knee arthroplasty procedures is substantially equivalent to currently marketed CAS systems.
"Our team is pleased to have achieved this important milestone. Since inception in 2008, we have taken significant steps forward with the development of our computer-assisted technology for orthopedic surgery, resulting in this market clearance", said Pieter Wolters, OrthAlign's President and CEO. "We believe that KneeAlign® will be cost effective and become the new standard of care in orthopedic surgery".
About OrthAlign, Inc.:
OrthAlign has developed disposable
palm-sized, computer-assisted surgical devices for use
in total jointreplacement. The company received
regulatory clearance for clinical use of its first
generation KneeAlign® product in the United States in
September 2009.
For more information, visit
www.orthalign.com.
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