UDI device identifier

SacroFuse 14-42001

UDI device identifier 00190361023272 · SPINEFRONTIER, INC.

Key facts

Primary DI 00190361023272
Brand name SacroFuse
Version or model 14-42001
Company SPINEFRONTIER, INC.
DUNS number 002003243
Product code HWR
GMDN term Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Premarket submission K150017
Device class Class I
Single use No
Packaged sterile No
Implantable Yes
Publish date Apr 5, 2019
Version date Nov 28, 2022
Description IMPACT SHAFT-DRIVER, INSERTER, SACROFUSE

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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