UDI device identifier

InSpan® IM61002-10

UDI device identifier 00190361000822 · SPINEFRONTIER, INC.

Key facts

Primary DI 00190361000822
Brand name InSpan®
Version or model IM61002-10
Company SPINEFRONTIER, INC.
DUNS number 002003243
Product code KWP
GMDN term Interspinous spinal fixation implant
Premarket submission K102020
Device class Class II
Single use Yes
Packaged sterile No
Implantable Yes
Publish date Apr 15, 2016
Version date Apr 23, 2019
Description ISP Plate, Assy, 16x43mm

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)