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SOCORE - Spinal Stabilization System, Sterile
EUDAMEDClass IIb (EU MDR)
Ref SC3512-A-SModel Monoaxial pedicle screws
by NovaSpine
Identity
- Device Name
- SOCORE - Spinal Stabilization System, Sterile EUDAMED
- Model / Reference
- Monoaxial pedicle screws EUDAMEDSC3512-A-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700482286998 EUDAMED
- Basic UDI-DI
- 37004822IMPSOCORES01TX EUDAMED
- EMDN Code
- P09070301 CERVICAL 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: Cervical spine immobilization system, single-use
SOCORE - Spinal Stabilization System, Sterile 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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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 | 37004822IMPSOCORES01TX | Class IIb | Active |
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Manufacturer
- Manufacturer
- NovaSpine
- EUDAMED SRN
- FR-MF-000007304
Sources (1)
- EUDAMED 8c22f47e-05d8-43e6-ba34-327a7ab79011 61 fields · synced Sep 18, 2026