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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
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
LARGE RATCHETING T-HANDLE WITH STRIKE PLATE; 1/4" DRIVE FDA UDI
Model / Reference
T080-0091 FDA UDI
Description
LARGE RATCHETING T-HANDLE WITH STRIKE PLATE; 1/4" DRIVE FDA UDI

Identifiers

Primary DI / UDI-DI
M697T08000911 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

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

Category: Surgical instrument handle, non-torque-limiting

Irix-A Lumbar Integrated Fusion System by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

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 7eac0a4b-7a54-47ad-8f05-ebb56848a8f7 34 fields · synced May 30, 2026