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SOCORE - Spinal Stabilization System
EUDAMEDClass IIb (EU MDR)
Ref SVO01Model Monoaxial pedicle screws
by NovaSpine
Identity
- Device Name
- SOCORE - Spinal Stabilization System EUDAMED
- Model / Reference
- Monoaxial pedicle screws EUDAMEDSVO01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700482214670 EUDAMED
- Basic UDI-DI
- 37004822IMPSOCORE001NM EUDAMED
- EMDN Code
- P09070301 CERVICAL 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: Cervical spine immobilization system, single-use
SOCORE - Spinal Stabilization System by NovaSpine — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Cervical spine immobilization system, single-use.
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- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- TST Spinal System — TST RAKOR VE TIBBİ ALETLER SAN.VE TİC.LTD.ŞTİ. · Class IIb
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 e3dfb358-1111-4a70-90f0-36a3b17c71ad 61 fields · synced Jun 19, 2026