FlareHawk

FDA UDI

Class II (US FDA UDI)

by Integrity Implants Inc.

Identity

Trade Name: FlareHawk FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Split Shim, 11 mm or 14 mm x 23 mm, 0 degree FDA UDI
Model / Reference: II-1-0390 FDA UDI
Description: Split Shim, 11 mm or 14 mm x 23 mm, 0 degree FDA UDI

Identifiers

Catalog Number: FHPAS40023S FDA UDI
Primary DI / UDI-DI: 00818613020755 FDA UDI
510(k) Number: K160076 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

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

Category: Metallic spinal interbody fusion cage

FlareHawk by Integrity Implants Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integrity Implants Inc.

Sources (1)

FDA UDI bbd4f025-ddc0-496f-aded-534ef96e5e79 36 fields · synced May 30, 2026