Eminent Spine, LLC - March 9, 2010
Issue Date
Mar 09, 2010
Region
Southwest
Category
Device
$117.00
Address 1
7200 N. Interstate 35
Address 2
Building 1
City
Georgetown
State
TX
Zip/Postal Code
78626
Country
US
Inspection Range
Mar 01, 2010 - Mar 09, 2010
Pages
8
First Observation
Design validation did not ensure that devices conform to defined user/patient needs and intended uses.
Investigator(s): Saijal Naik and Jeffrey R. Wooley