Identity
- Trade Name
- Cervical Trial 9/10 x 16 mm 8° EUDAMEDBEE FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Cervical Trial EUDAMEDAll instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques. FDA UDI
- Model / Reference
- I070 EUDAMEDCervical Trial 9/10 x 16 mm 8° FDA UDI
- Description
- All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques. FDA UDI
Identifiers
- Catalog Number
- I070 FDA UDI
- Primary DI / UDI-DI
- 04251631417057 EUDAMED04251631416517 EUDAMED04251631415732 EUDAMEDFDA UDI
- Basic UDI-DI
- 42516314TD020IIa4W EUDAMED
- Direct Marketing DI
- 04251631417057 EUDAMED04251631416517 EUDAMED04251631415732 EUDAMED
- 510(k) Number
- K200429 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cervical Trial 9/10 x 16 mm 8° by NGMedical GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42516314TD020IIa4W | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NGMedical GmbH
- EUDAMED SRN
- DE-MF-000000204
Sources (4)
- EUDAMED 1a9c6892-c2e6-4613-80e3-1efcd9e333f6 61 fields · synced Oct 6, 2026
- EUDAMED ba8059fc-f6cc-4b61-b5ae-8e2b30eda171 61 fields · synced May 19, 2026
- EUDAMED 2685e486-fc2e-4b17-8084-6e0c3826b568 61 fields · synced May 19, 2026
- FDA UDI b7c1f8b4-d544-4f50-9e0c-f68151942fb8 35 fields · synced May 29, 2026