Si-bone, Inc. - May 20, 2014
Issue Date
May 20, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Jeffrey W. Dunn
Contact Title
Chief Executive Officer (CEO) and President
Address 1
3055 Olin Ave.
Address 2
Suite 2200
City
San Jose
State
CA
Zip/Postal Code
95128-2066
Country
United States
Inspection Range
May 07, 2014 - May 20, 2014
Pages
3
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Linda Linh T. Nguyen