VADER® Pedicle System, Screw, Carbon/PEEK, Polyax., Fen. Ø 4.5 × 40 mm
EUDAMEDFDA UDIClass IIb (EU MDR)
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System, Screw, Carbon/PEEK, Polyax., Fen. Ø 4.5 × 40 mm EUDAMEDVADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 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 4.5 × 40 mm FDA UDI
- Model / Reference
- 16-6022-54540 EUDAMEDFDA UDI
- Description
- VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm FDA UDI
Identifiers
- Catalog Number
- 16-6022-54540 FDA UDI
- Primary DI / UDI-DI
- 07640172551561 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
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, Screw, Carbon/PEEK, Polyax., Fen. Ø 4.5 × 40 mm by icotec AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- 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 (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (2)
- EUDAMED ddfe61a0-2a76-467f-a15d-69df87b73233 61 fields · synced Jul 9, 2026
- FDA UDI b606f631-add4-4a60-8eef-fddf9f5bae54 35 fields · synced May 30, 2026