EUDAMED device

FlareHawk Interbody Fusion System

EUDAMED device 00810004723597 · Integrity Implants Inc.

Key facts

Primary DI 00810004723597
Trade name FlareHawk Interbody Fusion System
Device name Shim, 8mm or 11mm x 29 mm, 0 degree, FlareHawk 9
Reference or catalog number FHTAS10027X
Model CMP-00166
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 24, 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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