VADER® Pedicle System, S-Rod, Carbon/PEEK, multi curved, L1 Ø 6.0 ↔ 300 mm
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System, S-Rod, Carbon/PEEK, multi curved, L1 Ø 6.0 ↔ 300 mm EUDAMEDVADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, L1, 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, L1, Ø 6.0 x 300 mm FDA UDI
- Model / Reference
- 16-60-2MC30-4 EUDAMEDFDA UDI
- Description
- VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, L1, Ø 6.0 x 300 mm FDA UDI
Identifiers
- Catalog Number
- 16-60-2MC30-4 FDA UDI
- Primary DI / UDI-DI
- 07640172551745 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Spinal bone screw, non-bioabsorbable
VADER® Pedicle System, S-Rod, Carbon/PEEK, multi curved, L1 Ø 6.0 ↔ 300 mm by icotec AG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- 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 (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232628 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 764017255PSIRODBATi001QW | 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 (3)
- EUDAMED 375164b5-25c3-4ead-ac95-030a9bfeede3 61 fields · synced Jun 18, 2026
- FDA UDI d84439d3-aeb8-4243-a126-7c37bf17fb80 35 fields · synced May 30, 2026
- FDA 510(k) K232628 1 fields · synced May 18, 2026