Sterile and Non Sterile Spinal System
by Shandong Weigao Orthopaedic Device Company Limited. 241 variants
Part of a family of 92 devices: see the family pagePart of a family of 2,239+ devices: see the family page
Ref 800214520Model WGB1Z-7-01, WGB1Z-7-04
Sterile and Non Sterile Spinal System (800214520) is a device classified as Class IIb in the EU and Class II in the US made by Shandong Weigao Orthopaedic Device Company Limited., registered in EUDAMED on 9 Dec 2025 (Basic UDI-DI 6903095SPIWGB1Z701PPU9), cleared under FDA 510(k) K160320 on 1 Apr 2016 and listed in FDA GUDID since 5 Jul 2016 (UDI-DI 06912547086260), active as of 22 Oct 2026.
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number6903095SPIWGB1Z701PPU9 06912547086260 | Date9 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number06912547086260 | Date5 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK160320 | Date1 Apr 2016 | StatusActive |
Official records
- EUDAMED public site 6903095SPIWGB1Z701PPU9
- AccessGUDID record 06912547086260
- FDA 510(k) database K160320
Across registries
- EUDAMED Basic UDI-DI 6903095SPIWGB1Z701PPU9 registered 9 Dec 2025 Active
- FDA 510(k) K160320 decided 1 Apr 2016 Active
- FDA GUDID UDI-DI 06912547086260 listed 5 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K160320
- Listed FDA GUDID 06912547086260
- Registered EUDAMED 6903095SPIWGB1Z701PPU9
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Multi-Axial Screw
- Generic name
- Spinal bone screw, non-bioabsorbable
- Device name
- Sterile and Non Sterile Spinal System
- Model / reference
- WGB1Z-7-01 EUDAMED800214520 EUDAMEDWGB1Z-7-04 EUDAMED8214520 GUDID
- Primary DI / UDI-DI
- 06912547086260
- Basic UDI-DI
- 6903095SPIWGB1Z701PPU9, 6903095SPIWGB1Z704PRUU
- 510(k) Number
- FDA product code
- MNH, KWP, MNI
- EMDN code
- P09070302 Thoracolumbosacral fixation systems
- GMDN term
- Spinal bone screw, non-bioabsorbable
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 888.3070, 888.3050
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | WGB1Z-7-01 800214520 WGB1Z-7-04 | 8214520 |
| Device class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000019785
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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