FlareHawk Interbody Fusion System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref FHPACT0023SBModel ASY-00030

by Integrity Implants Inc.

Identity

Trade Name: FlareHawk Interbody Fusion System EUDAMED
FlareHawk FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: Shell, Tall 25 mm, FlareHawk 9 EUDAMEDFDA UDI
Model / Reference: ASY-00030 EUDAMEDFDA UDI
FHPACT0023SB EUDAMED
Description: Shell, Tall 25 mm, FlareHawk 9 FDA UDI

Identifiers

Catalog Number: FHPACT0023SB FDA UDI
Primary DI / UDI-DI: 00810004723481 EUDAMEDFDA UDI
Basic UDI-DI: B-00810004723481 EUDAMED
510(k) Number: K182114 FDA UDI
FDA Product Code: MAX FDA UDI
EMDN Code: P09070199 SPINAL FUSION SYSTEMS - OTHER EUDAMED
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

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

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

MRI Safety

MR Conditional FDA UDI

The FlareHawk Interbody Fusion System from MDSS GmbH is a Shell, Tall 25 mm, device designed for spine fusion procedures. It features an Integrity Implants Inc.-impressed design and is compatible with human tissues. This legacy system was released in the early 2000s and has undergone several updates over the years. With its sturdy construction and advanced implantation technology, it remains a reliable choice for surgeons.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-00810004723481	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

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

Sources (2)

EUDAMED 45a6d92d-557c-4d74-a2fa-9f7cbd116119 61 fields · synced Jul 19, 2026
FDA UDI fe63bd5e-a293-4ba2-afcf-9b29e0553e41 36 fields · synced May 30, 2026