Nano fx®

Basic Information

• Brand Name: Nano fx®
• Primary DI: M528FURS11010
• Version / Model: FURS-1101
• Catalog Number: FURS-1101
• 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: 349f5e0f-a199-4a37-a7d0-2aa369a04d50

Device Description

Pleuristik, NanoFracture, Hip

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
61411	Subchondral bone needling device	A sterile, metallic surgical instrument intended to be used to create thin channels in the bone layer beneath articular cartilage to enable migration of bone marrow (blood stem) cells to promote healing of a cartilage defect. Otherwise known as nanofracture, subchondral bone needling uses non-rotational force (hammering) during an arthroscopic procedure. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] in the form of a long thin spike with a bulbous proximal end and is typically used with a reusable handle (not included). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M528FURS11010	HIBCC

Customer Contacts

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