UDI device identifier

IdentiTi 134-2-35-12

UDI device identifier 00190376240589 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376240589
Brand name IdentiTi
Version or model 134-2-35-12
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code OVE
GMDN term Metallic spinal interbody fusion cage
Premarket submission K202812
Device class Class II
Single use Yes
Packaged sterile No
Implantable Yes
Publish date Mar 31, 2021
Version date Jul 14, 2025
Description CERVICAL SA BONE SCREW, SELF-DRILLING, DUAL LEAD, 3.5mm X 12mm

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

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

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

Browse all UDI device identifiers (GUDID)