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FlareHawk

FDA UDI

Class II (US FDA UDI)

by Integrity Implants Inc.

Identity

Trade Name
FlareHawk FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
Shell Assembly Tall 27mm Version B FDA UDI
Model / Reference
II-1-0173 FDA UDI
Description
Shell Assembly Tall 27mm Version B FDA UDI

Identifiers

Catalog Number
FHTA-CT-00-27-B FDA UDI
Primary DI / UDI-DI
00850231007473 FDA UDI
510(k) Number
K133514 FDA UDI
K160076 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K133514 also covers:

K160076 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrity Implants Inc.

Sources (1)

  • FDA UDI 93a7b058-b600-444b-a5d3-1b971a1e1fc4 37 fields · synced May 31, 2026