483
Z7 LLCZ7 LLC – FDA 483, Jan 21, 2025
Record Details
An FDA inspection of Z7 LLC, a medical device distributor in Whitehouse Station, NJ, identified a significant compliance issue. The firm failed to submit required information for its ZtNova Implants Systems, sterile dental implants, to the Global Unique Device Identification Database (GUDID). This indicates a lapse in regulatory reporting for medical device identification.
- Person
View Company Profile
ID · 1614eb6c-fa4b-484c-a924-e6801553da6e
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.