ORTHOFIX

Basic Information

• Brand Name: ORTHOFIX
• Primary DI: 18059015371048
• Version / Model: 1
• Catalog Number: 99-60003632
• Company Name: ORTHOFIX SRL
• Labeler DUNS: 438793622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-23
• Public Version: 4
• Public Version Date: 2025-10-24
• Public Version Status: Update
• Public Device Record Key: 7b9b5ede-1448-47c2-93db-639450c9b114

Device Description

FITBONE TRANSPORT LENGTHENING TRIAL NAIL TLN 1140-F-40-370 STERILE

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66957	Bone nail trial, single-use	A copy of a final orthopaedic bone nail designed to be introduced into the bone (e.g., proximal and/or distal end of the intramedullary canal of a long bone) to function as a reference for the subsequent introduction of the final bone nail, and typically also guide wire and/or bone screws. It is typically used in conjunction with appropriate holders/positioning devices (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	18059015371048	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232169	000

Device Sizes

Type	Value	Unit	Text
Length	370	Millimeter
Outer Diameter	11	Millimeter