Irix-A Lumbar Integrated Fusion System

FDA UDI

Class I (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Irix-A Lumbar Integrated Fusion System FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 11mm FDA UDI
Model / Reference: C080-0055 FDA UDI
Description: SPECIALTY IRIX A RASP ASSEMBLY 38X28X12 DEG 11mm FDA UDI

Identifiers

Primary DI / UDI-DI: M697C08000551 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

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

Category: Bone file/rasp, manual, reusable

Irix-A Lumbar Integrated Fusion System by Xtant Medical Holdings, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 1114e815-25f4-4f25-b3ab-dde64f282ab1 34 fields · synced Jun 8, 2026