Roi-A

FDA UDI

Class II (US FDA UDI)

by Ldr Spine USA

Identity

Trade Name: ROI-A FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: ROI-A TRIAL 23X33 H12 6° FDA UDI
Model / Reference: IR8213R FDA UDI
Description: ROI-A TRIAL 23X33 H12 6° FDA UDI

Identifiers

Catalog Number: IR8213R FDA UDI
Primary DI / UDI-DI: 03662663037921 FDA UDI
FDA Product Code: OVD FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Angle — 6 degree FDA UDI
Height — 12 Millimeter FDA UDI
Width — 33 Millimeter FDA UDI
Depth — 23 Millimeter FDA UDI

Category: Spinal implant trial

Roi-A by Ldr Spine USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ldr Spine USA

Sources (1)

FDA UDI c6d35144-88d0-48c4-b787-06aed8692d19 36 fields · synced Jun 8, 2026