FITBONE®

Basic Information

• Brand Name: FITBONE®
• Primary DI: 04260170143679
• Version / Model: CS 120V -A
• Catalog Number: 60001644
• Company Name: WITTENSTEIN intens GmbH
• Labeler DUNS: 315887799
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-17
• Public Version: 3
• Public Version Date: 2025-03-06
• Public Version Status: Update
• Public Device Record Key: 83974043-6da5-4bf7-8330-35c46772bc88
• Distribution End Date: 2022-12-31

Device Description

Control Set for activation of intramedullary lengthening nail

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43538	Distraction implant adjustment remote control	A portable, hand-held, electrically-powered device intended to noninvasively and remotely adjust the length of a previously-implanted extramedullary distraction plate and/or intramedullary distraction nail to correct long bone fractures and limb length discrepancies, and/or with spinal distraction rod to correct spinal deformities; it may be used intraoperatively to test the functionality of the implantable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260170143679	GS1

Customer Contacts

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