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Food and
Drug Administration
Orthopaedic and Rehabilitation Devices Panel
April 24, 2007
Briefing Information
Sponsor: Link America, Inc.
STAR Ankle
Disclaimer
The statements contained in this document(s) are those of
the product's sponsor, not FDA, and FDA does not necessarily
agree with the sponsor's statements. FDA has not made a final
determination about the safety or effectiveness of the product
described in this document.
Executive Summary (pdf)
FDA
Disclaimer
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the
FOIA) (5 U.S.C. §552). These redacted portions will appear
as white space on the screen or on the printed page.
FDA Executive Summary (pdf)
Panel Recommendation Options for Premarket Approval Applications (pdf)