Nano fx®

Basic Information

• Brand Name: Nano fx®
• Primary DI: M528550033100
• Version / Model: 5500-3310
• Catalog Number: 5500-3310
• Company Name: ARTHROSURFACE INCORPORATED
• Labeler DUNS: 144666109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5d0d8366-19d3-4d78-84fe-e455213f02f1

Device Description

Guide, Hip, 15o Nanofracture

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: Labeling does not contain MRI Safety Information
• 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
61412	Subchondral bone needling device handle	A hand-held manual surgical instrument designed as the handle for a subchondral bone needling device used during arthroscopic procedures to create thin channels through the bone layer beneath articular cartilage to enable migration of bone marrow (blood stem) cells to promote healing of a cartilage defect. It is made of plastic materials. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M528550033100	HIBCC

Customer Contacts

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