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EXPEDIUM and VIPER 2 SPINE SYSTEM
EUDAMEDClass IIb (EU MDR)
Ref 196789400SModel VIPER Spine System Rods
Identity
- Trade Name
- EXPEDIUM and VIPER 2 SPINE SYSTEM EUDAMED
- Device Name
- VIPER Spine System Straight Rods Straight Rod, Pre-Bent Rod, Pre-Kyphosed, Pre-Lordosed EUDAMED
- Model / Reference
- VIPER Spine System Rods EUDAMED196789400S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705034431857 EUDAMED
- Basic UDI-DI
- 0705034a002105H EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
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
Category: Spinal bone screw, non-bioabsorbable
EXPEDIUM and VIPER 2 SPINE SYSTEM by Medos International Sarl — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
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- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705034a002105H | Class IIb | Active |
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Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 012301dd-908c-4a70-999f-2c28c0e65e7c 61 fields · synced Jun 19, 2026