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Expedium Spine System
EUDAMEDFDA UDIClass I (EU MDR)
Ref 279712850Model Expedium Osteosynthesis Reusable Instruments
Identity
- Trade Name
- EXPEDIUM SPINE SYSTEM EUDAMEDEXPEDIUM FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- Expedium Bender Clamp Rod Claim Spreader Template Wire Twister EUDAMEDEXPEDIUM SPINE SYSTEM BENDER, RIGHT FDA UDI
- Model / Reference
- Expedium Osteosynthesis Reusable Instruments EUDAMED279712850 EUDAMEDFDA UDI
- Description
- EXPEDIUM SPINE SYSTEM BENDER, RIGHT FDA UDI
Identifiers
- Catalog Number
- 279712850 FDA UDI
- Primary DI / UDI-DI
- 10705034199108 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a001085R EUDAMED
- Direct Marketing DI
- 10705034199108 EUDAMED
- FDA Product Code
- HXW FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Category: Surgical implant template, reusable
Expedium Spine System by Medos International Sarl — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant template, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a001085R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 ab409791-497e-41a8-b6b4-5e48749f654e 61 fields · synced Jun 8, 2026
- FDA UDI d8ea0a28-546c-4240-86a1-be9a22066264 35 fields · synced May 30, 2026