EUDAMED device

FlareHawk Interbody Fusion System

EUDAMED device 00810004728745 · Integrity Implants Inc.

Key facts

Primary DI 00810004728745
Trade name FlareHawk Interbody Fusion System
Device name Thin Shaft Osteotome
Reference or catalog number ASY-00459
Model ASY-00459
Manufacturer Integrity Implants Inc.
Manufacturer SRN US-MF-000009805
Risk class Class I
EMDN code L090401
EMDN description ORTHOPAEDIC SURGERY OSTEOTOMES, 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:

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