Identity
- Trade Name
- ROMEO Posterior Osteosynthesis system FDA UDI
- Generic Name
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- Rod Cobalt Chromium / Prebent FDA UDI
- Model / Reference
- ELL-R8 13 50-S FDA UDI
- Description
- Rod Cobalt Chromium / Prebent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640151091316 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDI
- GMDN Term
- Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA 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
No
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
Dimensions & Sizes
- Size
- Length — 350 Millimeter FDA UDIOuter Diameter — 5.4 Millimeter FDA UDI
ROMEO Posterior Osteosynthesis system by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spineart
Sources (1)
- FDA UDI 0cec0a01-eaa3-43cc-a742-0327711c76aa 35 fields · synced May 31, 2026