Irix-A Lumbar Integrated Fusion System

FDA UDI

Class II (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Irix-A Lumbar Integrated Fusion System FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 12°, 11mm, PC FDA UDI
Model / Reference: X080-382811-12TPC FDA UDI
Description: IRIX-A INTEGRATED SPACER, TITANIUM ASSY, 38 X 28 X 12°, 11mm, PC FDA UDI

Identifiers

Primary DI / UDI-DI: M697X08038281112TPC1 FDA UDI
FDA Product Code: OVD FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 38 Millimeter FDA UDI
Height — 11 Millimeter FDA UDI
Length — 28 Millimeter FDA UDI
Angle — 12 degree FDA UDI

Irix-A Lumbar Integrated Fusion System by Xtant Medical Holdings, Inc. — 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: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 0afb1df7-6788-4c84-b166-a272e18900bc 36 fields · synced May 31, 2026