Establishment registration

ISOTIS ORTHOBIOLOGICS, INC

FDA establishment registration 2090010 · IRVINE, US

Key facts

Registration number 2090010
Establishment name ISOTIS ORTHOBIOLOGICS, INC
Owner/operator SeaSpine Orthopedics Corporation
Owner/operator number 10049589
FEI number 3001503333
Address 2 Goodyear
City IRVINE
State CA
Country US
Registration valid through 2026
Product codes listed MBP, MQV, NUN, OLO
Device classes 2

At a glance

  • 10–99 Device listings
  • 1,000+ UDI devices (GUDID)
  • Current Registration current
  • 10–99 FDA inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device establishment registrations

Device establishments that manufacture, repackage, relabel or import devices for the U.S. market must register annually with the FDA and list the devices they produce.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device establishment registrations