UDI device identifier

ATEC Porous Ti Interbody System 115-09221915

UDI device identifier 00190376102498 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376102498
Brand name ATEC Porous Ti Interbody System
Version or model 115-09221915
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code ODP
GMDN term Spinal implant trial
Premarket submission K183705
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Mar 2, 2020
Version date Mar 10, 2020
Description Cervical Trial, 9 x 22 x 19 - 15°

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:

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