Spineology, Inc. - Feb. 15, 2022
Issue Date
Feb 15, 2022
Region
Central
Category
Device
$117.00
Contact Name
John J . Booth
Contact Title
CEO
Address 1
7800 3rd St N.
Address 2
Ste. 600
City
Saint Paul
State
MN
Zip/Postal Code
55128-5455
Country
United States
Inspection Range
Feb 08, 2022 - Feb 15, 2022
Pages
4
First Observation
Software used as part of the quality system has not been adequately validated for its intended use
according to an established protocol.
Investigator(s): Christina L. Bigham and Albert L. Nguyen