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SOCORE - Spinal Stabilization System
EUDAMEDClass IIb (EU MDR)
Ref S6R60M2Model Monoaxial pedicle screws
by NovaSpine
Identity
- Device Name
- SOCORE - Spinal Stabilization System EUDAMED
- Model / Reference
- Monoaxial pedicle screws EUDAMEDS6R60M2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700482275909 EUDAMED
- Basic UDI-DI
- 37004822IMPSOCORE001NM EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
The SOCORE - Spinal Stabilization System is a cutting-edge, class IIb medical device that utilizes novel implantable materials to provide stable and secure spinal stabilization. Our proprietary technology enables effective treatment for various spinal conditions, offering unparalleled patient outcomes.
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 | 37004822IMPSOCORE001NM | Class IIb | Active |
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Manufacturer
- Manufacturer
- NovaSpine
- EUDAMED SRN
- FR-MF-000007304
Sources (1)
- EUDAMED 3a7c5709-0b75-4543-8d0a-d3799f410d8f 61 fields · synced Jul 29, 2026