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ROMEO posterior osteosynthesis system

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name
ROMEO posterior osteosynthesis system FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
MONOAXIAL SCREW FDA UDI
Model / Reference
ELL-MS 45 25-N FDA UDI
Description
MONOAXIAL SCREW FDA UDI

Identifiers

Catalog Number
ELL-MS 45 25-N FDA UDI
Primary DI / UDI-DI
07640139343925 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4.5 Millimeter FDA UDI
Length — 25 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

ROMEO posterior osteosynthesis system by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA UDI 1fe1990f-5678-4299-bbb5-a469948f4232 35 fields · synced May 30, 2026