ROMEO Posterior Osteosynthesis System

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name: ROMEO Posterior Osteosynthesis System FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Polyaxial Screw FDA UDI
Model / Reference: ELL-PS 08 30-S FDA UDI
Description: Polyaxial Screw FDA UDI

Identifiers

Primary DI / UDI-DI: 07640139345813 FDA UDI
FDA Product Code: KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 30 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

ROMEO Posterior Osteosynthesis System by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

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ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

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 d9e783ec-1647-4703-b66b-b8b66487412c 34 fields · synced May 31, 2026