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Sterile and Non-Sterile the Spinal Rod System(thoracolumbar)
EUDAMEDClass IIb (EU MDR)
Ref 62881545S
Identity
- Device Name
- Sterile and Non-Sterile the Spinal Rod System(thoracolumbar) EUDAMED
- Model / Reference
- 62881545S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941977526381 EUDAMED
- Basic UDI-DI
- 69426746P09070399GH EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Spinal bone screw, non-bioabsorbable
Sterile and Non-Sterile the Spinal Rod System(thoracolumbar) by Shanghai Sanyou Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED
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
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69426746P09070399GH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai Sanyou Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000004488
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 44437e4a-4cf5-4d1a-b1cb-ecd38303cba2 61 fields · synced Jun 19, 2026