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VADER® Pedicle System Nut Screw, Ti -
EUDAMEDClass IIb (EU MDR)
Ref 16-57-41000
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System Nut Screw, Ti - EUDAMED
- Device Name
- Pedicle System Nut Screw (Ti) EUDAMED
- Model / Reference
- 16-57-41000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640172554227 EUDAMED
- Basic UDI-DI
- 764017255PSINUTSTi0014F EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
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
Category: Spinal bone screw, non-bioabsorbable
VADER® Pedicle System Nut Screw, Ti - by icotec AG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Spinal bone screw, non-bioabsorbable.
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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 | 764017255PSINUTSTi0014F | Class IIb | Active |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (1)
- EUDAMED 5d8ce7af-200e-4536-a3e5-2f6d4fcf5b04 61 fields · synced Aug 1, 2026