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FlareHawk Interbody Fusion System
EUDAMEDFDA UDIClass I (EU MDR)
Ref FHTPKW1Model CMP-00482
Identity
- Trade Name
- FlareHawk Interbody Fusion System EUDAMEDNA FDA UDI
- Generic Name
- Spinal guidewire FDA UDI
- Device Name
- K-Wire, Blunt Tip, 508mmL, FlareHawk 7 EUDAMEDFDA UDI
- Model / Reference
- CMP-00482 EUDAMEDFDA UDIFHTPKW1 EUDAMED
- Description
- K-Wire, Blunt Tip, 508mmL, FlareHawk 7 FDA UDI
Identifiers
- Catalog Number
- FHTPKW1 FDA UDI
- Primary DI / UDI-DI
- 00810004722057 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810004722057 EUDAMED
- FDA Product Code
- HXI FDA UDI
- EMDN Code
- P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED
- GMDN Term
- Spinal guidewire FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
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
Yes
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-00810004722057 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 b998b6a5-5f47-487c-afd9-106ff4dc6397 61 fields · synced Jul 11, 2026
- FDA UDI c07b0806-dbda-4b6d-bae2-ccdf9eb71696 35 fields · synced May 30, 2026