Sterile and Non Sterile Spinal System
by Shandong Weigao Orthopaedic Device Company Limited. 241 variants
Part of a family of 2,239+ devices: see the family pagePart of a family of 67 devices: see the family page
Ref 800247045Model WGB1Z-7-08, WGB1Z-7-04
Sterile and Non Sterile Spinal System (800247045) 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 11 Mar 2026 (Basic UDI-DI 6903095SPIWGB1Z708MRV7), cleared under FDA 510(k) K160320 on 1 Apr 2016 and listed in FDA GUDID since 7 Jul 2016 (UDI-DI 06939488331952), 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 | Number6903095SPIWGB1Z708MRV7 06939488331952 | Date11 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06939488331952 | Date7 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK160320 | Date1 Apr 2016 | StatusActive |
Official records
- EUDAMED public site 6903095SPIWGB1Z708MRV7
- AccessGUDID record 06939488331952
- FDA 510(k) database K160320
Across registries
- EUDAMED Basic UDI-DI 6903095SPIWGB1Z708MRV7 registered 11 Mar 2026 Active
- FDA 510(k) K160320 decided 1 Apr 2016 Active
- FDA GUDID UDI-DI 06939488331952 listed 7 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K160320
- Listed FDA GUDID 06939488331952
- Registered EUDAMED 6903095SPIWGB1Z708MRV7
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Fixed-Angle Reduction Screw
- Generic name
- Spinal bone screw, non-bioabsorbable
- Device name
- Sterile and Non Sterile Spinal System
- Model / reference
- WGB1Z-7-08 EUDAMED800247045 EUDAMEDWGB1Z-7-04 EUDAMED8247045 GUDID
- Primary DI / UDI-DI
- 06939488331952
- Basic UDI-DI
- 6903095SPIWGB1Z708MRV7, 6903095SPIWGB1Z704PRUU
- 510(k) Number
- FDA product code
- MNI, KWP, MNH
- 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-7-08 800247045 WGB1Z-7-04 | 8247045 |
| 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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