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Axle Interspinous Fusion System

FDA UDI

Class I (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name
Axle Interspinous Fusion System FDA UDI
Generic Name
Lumbar interspinous decompression instrument set, reusable FDA UDI
Device Name
Torque Limiting T-Handle, AO Connect FDA UDI
Model / Reference
X060-0322 FDA UDI
Description
Torque Limiting T-Handle, AO Connect FDA UDI

Identifiers

Primary DI / UDI-DI
M697X06003221 FDA UDI
FDA Product Code
HXC FDA UDI
GMDN Term
Lumbar interspinous decompression instrument set, reusable 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: Lumbar interspinous decompression instrument set, reusable

Axle Interspinous Fusion System by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar interspinous decompression instrument set, reusable.

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 e22e8c1a-2522-478c-b013-66cb6a4946e1 34 fields · synced May 30, 2026