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High V+ - Spinal cement system
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref T040321K
by Teknimed Sas
Identity
- Trade Name
- High V+ - Spinal cement system EUDAMEDHIGH V+ SPINAL CEMENT SYSTEM FDA UDI
- Generic Name
- Orthopaedic cement preparation/delivery kit FDA UDI
- Device Name
- HIGHV+ - Spinal Cement System EUDAMED
- Model / Reference
- T040321K EUDAMEDFDA UDI
Identifiers
- Catalog Number
- T040321K FDA UDI
- Primary DI / UDI-DI
- 03760177043084 EUDAMEDFDA UDI
- Basic UDI-DI
- 376017704B28DE EUDAMED
- FDA Product Code
- NDN FDA UDI
- EMDN Code
- P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
- GMDN Term
- Orthopaedic cement preparation/delivery kit FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Medical Purpose
- The system is intended to mix and inject high viscosity bone cement during cementoplasty procedures EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
High V+ - Spinal cement system by Teknimed Sas — Class III — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161114 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 376017704B28DE | Class III | Active |
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Manufacturer
- Manufacturer
- Teknimed Sas
- EUDAMED SRN
- FR-PR-000001226
Sources (3)
- EUDAMED 846598eb-4faf-4af9-b157-eff8beb870bc 61 fields · synced Jun 18, 2026
- FDA UDI c3772073-94dd-4271-a3a2-cda1deb0aea5 34 fields · synced May 30, 2026
- FDA 510(k) K161114 1 fields · synced May 18, 2026