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TST Spinal System
EUDAMEDClass IIb (EU MDR)
Ref 74020000078Model ANTERIOR CERVICAL PLATE
Identity
- Trade Name
- TST Spinal System EUDAMED
- Device Name
- LOCK. ANTERIOR CERVICAL PLATE 78 MM EUDAMED
- Model / Reference
- ANTERIOR CERVICAL PLATE EUDAMED74020000078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698673424609 EUDAMED
- Basic UDI-DI
- B-08698673424609 EUDAMED
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
TST Spinal System by Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cervical spine immobilization system, single-use.
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- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08698673424609 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Tst Rakor Ve Tibbi̇ Aletler San.ve Ti̇c.ltd.şti̇.
- EUDAMED SRN
- TR-MF-000017767
Sources (1)
- EUDAMED 9f8a891a-7988-4247-a1d0-109353aa0ef8 61 fields · synced Jun 17, 2026