Sterile and Non Sterile Spinal System
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Connection Rod FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Sterile and Non Sterile Spinal System EUDAMED
- Model / Reference
- WGB1Z-7-23 EUDAMED800005110 EUDAMED8005110 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06912547138204 EUDAMEDFDA UDI
- Basic UDI-DI
- 6903095SPIWGB1Z723RDUF 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
- Bone-screw internal spinal fixation system rod 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.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- 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 (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6903095SPIWGB1Z723RDUF | 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 278f790f-7a10-4a24-b437-01ad5c19ec8a 61 fields · synced Jul 12, 2026
- FDA UDI 6bbd4760-ff83-4f24-8eb6-29639f1e9799 33 fields · synced May 30, 2026