FlareHawk Interbody Fusion System 4mm Up Pituitary

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref ASY-00446

by Integrity Implants Inc.

Identity

Trade Name: FlareHawk Interbody Fusion System EUDAMED
N/A FDA UDI
Generic Name: Spinal rongeur FDA UDI
Device Name: 4mm Up Pituitary EUDAMEDFDA UDI
Model / Reference: ASY-00446 EUDAMEDFDA UDI
Description: 4mm Up Pituitary FDA UDI

Identifiers

Catalog Number: ASY-00446 FDA UDI
Primary DI / UDI-DI: 00810004728615 EUDAMEDFDA UDI
Basic UDI-DI: B-00810004728615 EUDAMED
FDA Product Code: HTX FDA UDI
EMDN Code: L091307 ORTHOPAEDIC SURGERY RONGEURS, REUSABLE EUDAMED
GMDN Term: Spinal rongeur FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 888.4540 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

The FlareHawk Interbody Fusion System is a Class I device used for interbody fusion procedures. It is designed to facilitate spinal fusion by providing structural support between vertebrae.

This device is reusable and non-implantable, supplied sterile. It is model ASY-00446 and has FDA 510K and MDD authorizations. The device is not for use with MRI and should be stored according to manufacturer instructions.

Frequently asked questions

What is the FlareHawk Interbody Fusion System used for?

The FlareHawk Interbody Fusion System is a Class I device designed to facilitate spinal fusion by providing structural support between vertebrae during interbody fusion procedures.

Is the FlareHawk device reusable or single-use?

The FlareHawk Interbody Fusion System is reusable and non-implantable. It is supplied sterile and should be stored according to the manufacturer's instructions.

What are the regulatory authorizations for the FlareHawk system?

The FlareHawk Interbody Fusion System has FDA 510K and MDD authorizations. It is model ASY-00446 and is not for use with MRI.

How is the FlareHawk Interbody Fusion System supplied?

The device is supplied sterile and is reusable. It is model ASY-00446 and should be stored according to the manufacturer's instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K182114	Class I	Active
FDA 510(k)	United States	FDA_510K	K202198	Class I	Active
FDA 510(k)	United States	FDA_510K	K183184	Class I	Active
FDA 510(k)	United States	FDA_510K	K220453	Class I	Active
EUDAMED	European Union	CE/MDD	B-00810004728615	Class I	Active

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Manufacturer

Manufacturer: Integrity Implants Inc.
EUDAMED SRN: US-MF-000009805
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (3)

EUDAMED 7e0a17fd-305f-4240-945e-eda4c2ea6790 61 fields · synced Sep 21, 2026
FDA UDI 47851246-a241-437b-91c8-c2ab9b7fc1b5 35 fields · synced May 27, 2026
FDA 510(k) K182114 1 fields · synced May 18, 2026