EUDAMED device

FlareHawk Interbody Fusion System

EUDAMED device 00810004728646 · Integrity Implants Inc.

Key facts

Primary DI 00810004728646
Trade name FlareHawk Interbody Fusion System
Device name 3mm Kerrison
Reference or catalog number ASY-00449
Model ASY-00449
Manufacturer Integrity Implants Inc.
Manufacturer SRN US-MF-000009805
Risk class Class I
EMDN code L091307
EMDN description ORTHOPAEDIC SURGERY RONGEURS, 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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