EUDAMED device
FlareHawk Interbody Fusion System
EUDAMED device 00818613021264 · Integrity Implants Inc.
Key facts
| Primary DI | 00818613021264 |
|---|---|
| Trade name | FlareHawk Interbody Fusion System |
| Device name | Shell, Lordotic 25 mm, FlareHawk 9 |
| Reference or catalog number | FHPACT0923H |
| Model | ASY-00029 |
| Manufacturer | Integrity Implants Inc. |
| Manufacturer SRN | US-MF-000009805 |
| Risk class | Class IIb |
| EMDN code | P09070199 |
| EMDN description | SPINAL FUSION SYSTEMS - OTHER |
| Legislation | mdd |
| Implantable | Yes |
| Sterile | No |
| Single use | Yes |
| Status date | Jun 27, 2022 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: