SINO monoaxial pedicle screw
by Shandong Weigao Orthopaedic Device Company Limited. 32 variants
Ref 800126060, 800124540, 800124550, 800126570, 800127025, 800127570, 800125055, 800126040, 800127045, 800127545, 800124555, 800124030, 800127550, 800125540, 800126530, 800126070, 800125570, 800124530, 800125025, 800127065, 800127040, 800124535, 800126580, 800126555, 800127055, 800127555, 800127075, 800126050, 800124025, 800124035, 800125525, 800127035, 800125035, 800126030, 800125030, 800127565, 800126550, 800127540, 800125555, 800125545, 800124050, 800126065, 800125560, 800125535, 800126525, 800126025, 800127530, 800127050Model WGB1Z-1, WGB1Z-7-04
Active
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6903095SPIWGB1Z1MO5U | Date9 Oct 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Sterile and Non Sterile Spinal System
- Model / Reference
- WGB1Z-1, 800126060, 800124540, 800124550, 800126570, 800127025, 800127570, 800125055, 800126040, 800127045, 800127545, 800124555, 800124030, 800127550, 800125540, 800126530, 800126070, 800125570, 800124530, 800125025, 800127065, 800127040, 800124535, 800126580, 800126555, 800127055, 800127555, 800127075, 800126050, 800124025, 800124035, 800125525, 800127035, 800125035, 800126030, 800125030, 800127565, 800126550, 800127540, 800125555, 800125545, 800124050, 800126065, 800125560, 800125535, 800126525, 800126025, 800127530, 800127050, WGB1Z-7-04
- Primary DI / UDI-DI
- 06939488327948, 06939488327696, 06939488327719, 06912547148197, 06939488328051, 06912547148258, 06939488327795, 06939488327900, 06939488328099, 06939488328181, 06939488327726, 06939488327610, 06939488328198, 06939488327832, 06939488327979, 06912547148180, 06912547148173, 06939488327672, 06939488327733, 06939488328136, 06939488328082, 06939488327689, 06912547148210, 06939488328020, 06939488328112, 06939488328204, 06912547148234, 06939488327924, 06939488327603, 06939488327627, 06939488327801, 06939488328075, 06939488327757, 06939488327887, 06939488327740, 06939488328228, 06939488328013, 06939488328174, 06939488327863, 06939488327849, 06939488327658, 06939488327955, 06912547148159, 06939488327825, 06939488327962, 06939488327870, 06939488328150, 06939488328105
- Basic UDI-DI
- 6903095SPIWGB1Z1MO5U, 6903095SPIWGB1Z704PRUU
- EMDN Code
- P09070302 Thoracolumbosacral fixation systems
- Device Class
- Class IIb
- EU market of registration
- LithuaniaGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000019785
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (12)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- 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