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FlareHawk Interbody Fusion System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref FHTACT0927HModel ASY-00046
Identity
- Trade Name
- FlareHawk Interbody Fusion System EUDAMEDFlareHawk FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- Shell, Lordotic 29 mm, FlareHawk 9 EUDAMEDFDA UDI
- Model / Reference
- ASY-00046 EUDAMEDFDA UDIFHTACT0927H EUDAMED
- Description
- Shell, Lordotic 29 mm, FlareHawk 9 FDA UDI
Identifiers
- Catalog Number
- FHTACT0927H FDA UDI
- Primary DI / UDI-DI
- 00818613021295 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00818613021295 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 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
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
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
MR Conditional FDA UDI
FlareHawk Interbody Fusion System by Integrity Implants Inc. — Class IIb — 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-00818613021295 | 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 4bf6e327-f8a5-41cc-a859-619c64d5b2db 61 fields · synced May 30, 2026
- FDA UDI 5e454df0-623c-4663-9dcc-b77809f8fdc9 36 fields · synced May 30, 2026