Identity
- Trade Name
- FlareHawk Interbody Fusion System EUDAMEDFlareHawk FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- FH9 Expandable Trial, 9 degree EUDAMEDFDA UDI
- Model / Reference
- ASY-00337 EUDAMEDFDA UDI
- Description
- FH9 Expandable Trial, 9 degree FDA UDI
Identifiers
- Catalog Number
- ASY-00337 FDA UDI
- Primary DI / UDI-DI
- 00810004727588 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810004727588 EUDAMED
- 510(k) Number
- K182114 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- P090799 SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
FlareHawk Interbody Fusion System by Integrity Implants Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00810004727588 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integrity Implants Inc.
- EUDAMED SRN
- US-MF-000009805
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2cf88b44-8d28-4b62-8621-471837274893 61 fields · synced May 31, 2026
- FDA UDI 92bdd2e0-60df-4c57-8455-8cee6426b215 36 fields · synced May 27, 2026