Elite Expandable Interbody Fusion System

Basic Information

• Brand Name: Elite Expandable Interbody Fusion System
• Primary DI: M7403010025
• Version / Model: 35-04-02-1
• Catalog Number: 301-0025
• Company Name: SPINEOLOGY INC.
• Labeler DUNS: 033014361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-20
• Public Version: 1
• Public Version Date: 2023-12-28
• Public Version Status: New
• Public Device Record Key: 02620d01-754a-4c8b-95b9-dd8a30788eef

Device Description

10mm Paddle Distractor

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66936	Spinal intraoperative positioning pin, reusable	A nonimplantable thin rod intended to be temporarily introduced, with a dedicated inserter (not included), into vertebral bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7403010025	HIBCC

Customer Contacts

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