Aesculap Implant Systems, LLC - Aug. 11, 2021
Issue Date
Aug 11, 2021
Region
Central
Category
Device
$117.00
Contact Name
Kamaal Anas
Contact Title
Vice President of Regulatory Affairs and Quality
Address 1
3773 Corporate Pkwy.
City
Center Valley
State
PA
Zip/Postal Code
18034-8217
Country
United States
Inspection Range
Aug 03, 2021 - Aug 11, 2021
Pages
5
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Brian S. Keefer