Axle Interspinous Fusion System

Basic Information

• Brand Name: Axle Interspinous Fusion System
• Primary DI: M697X06002501
• Version / Model: X060-0250
• Company Name: Xtant Medical Holdings, Inc.
• Labeler DUNS: 081224143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-17
• Public Version: 5
• Public Version Date: 2021-06-03
• Public Version Status: Update
• Public Device Record Key: 9ed8b540-5fb1-4a28-a571-87399b2c5819

Device Description

Axle Insert, PEEK, 8mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEK	Spinous process plate	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61532	Lumbar interspinous decompression spacer, non-sterile	A non-sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M697X06002501	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	8	Millimeter
Length	36	Millimeter