FITBONE®

Basic Information

• Brand Name: FITBONE®
• Primary DI: 04260170140890
• Version / Model: STRE TAA1160
• Catalog Number: 60001415
• Company Name: WITTENSTEIN intens GmbH
• Labeler DUNS: 315887799
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-12
• Public Version: 4
• Public Version Date: 2023-01-06
• Public Version Status: Update
• Public Device Record Key: f4b4871f-3892-4a8b-8aab-805539238d1b
• Distribution End Date: 2022-12-31

Device Description

Step reamer TAA1160

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45115	Medullary canal orthopaedic reamer, rigid	An orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. 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	04260170140890	GS1

Customer Contacts

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