Identity
- Trade Name
- FlareHawk FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- Shell, Tall 23mm, Split Shim FDA UDI
- Model / Reference
- II-1-0453 FDA UDI
- Description
- Shell, Tall 23mm, Split Shim FDA UDI
Identifiers
- Catalog Number
- FHPA-CT-00-23-B2 FDA UDI
- Primary DI / UDI-DI
- 00818613020717 FDA UDI
- 510(k) Number
- 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
- 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Polymeric 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 Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- S-LIFT® — SPINEFRONTIER, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Cleared under the same submission
K160076 also covers:
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
- FlareHawk — Integrity Implants Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integrity Implants Inc.
Sources (1)
- FDA UDI 508fb8f0-4042-4d36-8368-f8c5233c5145 36 fields · synced Jun 8, 2026