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X Spine Systems, Inc. - May 7, 2009
Issue Date
May 07, 2009
Region
Central
Category
Device
$117.00
Address 1
452 Alexandersville Rd.
City
Miamisburg
State
OH
Zip/Postal Code
45342-3658
Country
US
Inspection Range
May 04, 2009 - May 07, 2009
Pages
2
First Observation
The written MDR procedure does not include an internal system which provides for timely transmission of complete medical reports to FDA.
Investigator(s): Laureen M. Geniusz and Christine E. Kelley