UDI device identifier
FacetFuse® IM0001
UDI device identifier 00190361020134 · SPINEFRONTIER, INC.
Key facts
| Primary DI | 00190361020134 |
|---|---|
| Brand name | FacetFuse® |
| Version or model | IM0001 |
| Company | SPINEFRONTIER, INC. |
| DUNS number | 002003243 |
| Product code | MRW |
| GMDN term | Trans-facet-screw internal spinal fixation system, sterile |
| Premarket submission | K071420 |
| Device class | Unclassified |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Apr 15, 2016 |
| Version date | Jul 2, 2025 |
| Description | Facet Screw, 4.5mm x 35mm |
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: