EUDAMED device
FlareHawk Interbody Fusion System
EUDAMED device 00810004728684 · Integrity Implants Inc.
Key facts
| Primary DI | 00810004728684 |
|---|---|
| Trade name | FlareHawk Interbody Fusion System |
| Device name | Penfield Dissector Up |
| Reference or catalog number | ASY-00453 |
| Model | ASY-00453 |
| Manufacturer | Integrity Implants Inc. |
| Manufacturer SRN | US-MF-000009805 |
| Risk class | Class I |
| EMDN code | L0315 |
| EMDN description | GENERAL SURGERY DISSECTORS, REUSABLE |
| Legislation | mdd |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Jun 8, 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: