[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 16, 2008
Last updated: March 22, 2016
Last verified: NA

Responsible Party: [Redacted]
ClinicalTrials.gov Identifier: NCT00680251     History of Changes
Other Study ID Numbers: ORTHO.CR.K015 
Study First Received: May 16, 2008
Last Updated: March 22, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on May 02, 2016

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