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VADER® Pedicle System Screw, Carbon/PEEK, Polyax., Fen. Ø 7.5 x 45 mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 16-6022-57545
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System Screw, Carbon/PEEK, Polyax., Fen. Ø 7.5 x 45 mm EUDAMEDVADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 45 mm FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Pedicle Screw (Carbon/PEEK) EUDAMEDVADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 45 mm FDA UDI
- Model / Reference
- 16-6022-57545 EUDAMEDFDA UDI
- Description
- VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 7.5 x 45 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640164844817 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255PSISCRBA00185 EUDAMED
- FDA Product Code
- NKB FDA UDIPML FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3027 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
VADER® Pedicle System Screw, Carbon/PEEK, Polyax., Fen. Ø 7.5 x 45 mm by icotec AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 764017255PSISCRBA00185 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (2)
- EUDAMED 2ab58a2c-50a3-4415-a9a4-d51c3c0d46a2 61 fields · synced Oct 6, 2026
- FDA UDI f34e17f8-0f49-4f98-8d9c-a9791060477f 34 fields · synced May 29, 2026