Sterile and Non Sterile Spinal System
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Fixed-Angle Screw FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Sterile and Non Sterile Spinal System EUDAMED
- Model / Reference
- WGB1Z-7-06 EUDAMED800235550 EUDAMED8235550 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06939488395664 EUDAMEDFDA UDI
- Basic UDI-DI
- 6903095SPIWGB1Z706MPUR EUDAMED
- 510(k) Number
- K160320 FDA UDI
- FDA Product Code
- MNH FDA UDIKWP FDA UDIMNI 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 UDI888.3050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Spinal bone screw, non-bioabsorbable
Sterile and Non Sterile Spinal System by Shandong Weigao Orthopaedic Device Company Limited. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
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- EVEREST® Spinal System — K2M, INC. · Class II
- Insignia — ALPHATEC SPINE, 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 | 6903095SPIWGB1Z706MPUR | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 (2)
- EUDAMED a855d2b3-07c1-4ca5-b75c-cd4561ea2f14 61 fields · synced Jun 18, 2026
- FDA UDI bff6d2c0-5046-4c0b-b252-057cc00f07db 33 fields · synced May 25, 2026