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VADER® Pedicle System, S-Rod, Carbon/PEEK, multi curved, TL1 Ø 6.0 ↔ 300 mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 16-60-2MC30-3
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System, S-Rod, Carbon/PEEK, multi curved, TL1 Ø 6.0 ↔ 300 mm EUDAMEDVADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, TL1, Ø 6.0 x 300 mm FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Pedicle Rod (Carbon/PEEK, Ti marker) EUDAMEDVADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, TL1, Ø 6.0 x 300 mm FDA UDI
- Model / Reference
- 16-60-2MC30-3 EUDAMEDFDA UDI
- Description
- VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, TL1, Ø 6.0 x 300 mm FDA UDI
Identifiers
- Catalog Number
- 16-60-2MC30-3 FDA UDI
- Primary DI / UDI-DI
- 07640172551738 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255PSIRODBATi001QW EUDAMED
- FDA Product Code
- NKB FDA UDIPML FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod 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, S-Rod, Carbon/PEEK, multi curved, TL1 Ø 6.0 ↔ 300 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 | 764017255PSIRODBATi001QW | 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 abcd810e-164b-41ea-8a05-5295f585ac33 61 fields · synced Jun 19, 2026
- FDA UDI 09d07815-c260-4518-a32d-0eea157e2d3e 35 fields · synced May 30, 2026