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Sterile and Non Sterile Spinal System
EUDAMEDClass IIb (EU MDR)
Ref 810127045Model WGB1Z-1
Identity
- Device Name
- Sterile and Non Sterile Spinal System EUDAMED
- Model / Reference
- WGB1Z-1 EUDAMED810127045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06912547427568 EUDAMED
- Basic UDI-DI
- 6903095SSPWGB1Z1MODL 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
Sterile and Non Sterile Spinal System by Shandong Weigao Orthopaedic Device Company Limited. — Class IIb — MDR — listed in EUDAMED
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Also classified as Spinal bone screw, non-bioabsorbable.
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- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- EVEREST® Spinal System — K2M, INC. · Class II
- Insignia — ALPHATEC SPINE, INC. · Class II
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 | 6903095SSPWGB1Z1MODL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shandong Weigao Orthopaedic Device Company Limited.
- EUDAMED SRN
- CN-MF-000019785
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3d65dc0f-3a49-48c2-9291-d269cbcddb53 61 fields · synced Jun 18, 2026