Healix Advance Anchor Open Hard Bone Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- HEALIX ADVANCE ANCHOR OPEN HARD BONE KIT EUDAMEDHEALIX ADVANCE FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- Healix Advance Hard Bone Disposable Kit EUDAMEDHEALIX ADVANCE ANCHOR OPEN HARD BONE KIT Open Instrumentation Kit for 4.5mm and 4.75 HEALIX ADVANCE Anchors (1) 3.5mm Drill Bit(1) 4.5mm Full Tap(1) OS-6 Needle Loop 3.5mm and 4.5mm FDA UDI
- Model / Reference
- Healix Advance Hard Bone Disposable Kit EUDAMED222358 EUDAMEDFDA UDI
- Description
- HEALIX ADVANCE ANCHOR OPEN HARD BONE KIT Open Instrumentation Kit for 4.5mm and 4.75 HEALIX ADVANCE Anchors (1) 3.5mm Drill Bit(1) 4.5mm Full Tap(1) OS-6 Needle Loop 3.5mm and 4.5mm FDA UDI
Identifiers
- Catalog Number
- 222358 FDA UDI
- Primary DI / UDI-DI
- 10886705027781 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00068KR EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bone tap, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Joint prosthesis implantation kit, single-use
Healix Advance Anchor Open Hard Bone Kit by Medos International Sarl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0886705a00068KR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (2)
- EUDAMED c145d7fa-4446-4c04-b824-5b4ff3d69a53 61 fields · synced Jul 30, 2026
- FDA UDI cf6d71e9-9ce1-4999-94be-bca01d047215 35 fields · synced May 29, 2026