← Back to catalogue
Normmed Polyaxial Listhesis Dual Threaded Screw 7.0X55 mm + Set Screw
EUDAMEDClass IIb (EU MDR)
Ref NMSPAKR7055Ref NMSPAK7055
Identity
- Device Name
- Normmed Polyaxial Listhesis Dual Threaded Screw 7.0X55 mm + Set Screw EUDAMEDNormmed Polyaxial Dual Threaded Screw 7.0X55 mm + Set Screw EUDAMED
- Model / Reference
- NMSPAKR7055 EUDAMEDNMSPAK7055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680487033016 EUDAMED08680487019959 EUDAMED
- Basic UDI-DI
- B-08680487033016 EUDAMEDB-08680487019959 EUDAMED
- EMDN Code
- P09070302 THORACOLUMBOSACRAL 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: Spinal bone screw, non-bioabsorbable
Normmed Polyaxial Listhesis Dual Threaded Screw 7.0X55 mm + Set Screw by Normmed Medi̇kal San. Ve Ti̇c. A.ş. — Class IIb — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08680487033016 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Normmed Medi̇kal San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000015713
Sources (2)
- EUDAMED 4df85692-67f1-4a8c-b17f-b706cb6859d4 61 fields · synced Jul 26, 2026
- EUDAMED 99e1f4f0-f549-4516-8c31-97862a16e619 61 fields · synced May 18, 2026