Axle Interspinous Fusion System

Basic Information

• Brand Name: Axle Interspinous Fusion System
• Primary DI: M697X08042301512PCSTR1
• Version / Model: X080-423015-12PC-STR
• Company Name: Xtant Medical Holdings, Inc.
• Labeler DUNS: 081224143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-31
• Public Version: 4
• Public Version Date: 2021-06-03
• Public Version Status: Update
• Public Device Record Key: 0ffa58d2-e6b3-4000-8c32-99edf6266681

Device Description

IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 12°, 15mm, PC (STERILE)

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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVD	Intervertebral fusion device with integrated fixation, lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60847	Polymeric spinal fusion cage, sterile	A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable devices associated with implantation may be included with the device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M697X08042301512PCSTR1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	42	Millimeter
Height	15	Millimeter
Length	30	Millimeter
Angle	12	degree