Roi-A

FDA UDI

Class II (US FDA UDI)

by Ldr Spine USA

Identity

Trade Name: ROI-A FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Device Name: ROI-A MEDIAN IMPLANT PXL 30X33 H12 10° FDA UDI
Model / Reference: IR2632P FDA UDI
Description: ROI-A MEDIAN IMPLANT PXL 30X33 H12 10° FDA UDI

Identifiers

Primary DI / UDI-DI: 03662663011648 FDA UDI
FDA Product Code: OVD FDA UDI
MQP FDA UDI
MAX FDA UDI
GMDN Term: Polymeric spinal fusion cage, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Angle — 10 degree FDA UDI
Width — 33 Millimeter FDA UDI
Depth — 30 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI

Category: Polymeric spinal fusion cage, sterile

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 01aeeae6-4de5-4a4c-96bf-05d686445a3d 35 fields · synced May 31, 2026