UDI device identifier

Insignia 136-2-14016

UDI device identifier 00190376266183 · ALPHATEC SPINE, INC.

Key facts

Primary DI 00190376266183
Brand name Insignia
Version or model 136-2-14016
Company ALPHATEC SPINE, INC.
DUNS number 602465783
Product code KWQ
GMDN term Spinal bone screw, non-bioabsorbable
Premarket submission K200995
Device class Class II
Single use Yes
Packaged sterile No
Implantable Yes
Publish date Dec 30, 2020
Version date Sep 11, 2024
Description 4.0mm Variable Angle, Self Tapping Screw, Dual Lead 16mm

At a glance

  • 1–9 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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