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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, 33 X 26 X 8°, 17mm FDA UDI
Model / Reference
X080-332617-08T FDA UDI
Description
IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 8°, 17mm FDA UDI

Identifiers

Primary DI / UDI-DI
M697X08033261708T1 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 17 Millimeter FDA UDI
Length — 26 Millimeter FDA UDI
Angle — 8 degree FDA UDI
Width — 33 Millimeter 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

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Manufacturer

Manufacturer
Xtant Medical Holdings, Inc.

Sources (1)

  • FDA UDI 8499c73d-9561-4278-bb5e-031b6ef047f8 36 fields · synced Jun 1, 2026