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Nts
EUDAMEDFDA UDIClass I (EU MDR)
Ref D4210200Model Racks and Support, Reusable
Identity
- Trade Name
- NTS EUDAMEDNuVasive FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Racks and Support, Reusable EUDAMEDNTS Rack, Tube FDA UDI
- Model / Reference
- Racks and Support, Reusable EUDAMEDD4210200 EUDAMEDFDA UDI
- Description
- NTS Rack, Tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195377106629 EUDAMEDFDA UDI
- Basic UDI-DI
- 0887517RCKSPT65 EUDAMED
- Direct Marketing DI
- 00195377106629 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Internal spinal fixation procedure kit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, reusable
Nts by Nuvasive, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0887517RCKSPT65 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NuVasive, LLC
- EUDAMED SRN
- US-MF-000007421
- Authorised Representative
- AJW Technology Consulting GmbH DE-AR-000004999
Sources (2)
- EUDAMED 6a1ed531-5641-44bd-a9df-8d806ee1e858 61 fields · synced Oct 7, 2026
- FDA UDI bcb1a627-c26e-4150-854f-ed56fe58fc4b 34 fields · synced May 30, 2026