Arthrosurface, Inc. - Oct. 5, 2015
Issue Date
Oct 15, 2015
Region
Northeast
Category
Device
$117.00
Contact Name
Steven W. Ek
Contact Title
President and CEO
Address 1
28 Forge Pkwy.
City
Franklin
State
MA
Zip/Postal Code
02038
Country
United States
Inspection Range
Sep 15, 2016 - Oct 05, 2016
Pages
7
First Observation
The design was not validated using initial production units, lots or batches or their equivalents.
Investigator(s): Elizabeth B. Griffin