TriLeap Lower Extremity Anatomic Plating System

Basic Information

• Brand Name: TriLeap Lower Extremity Anatomic Plating System
• Primary DI: 00810112596236
• Version / Model: Compression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thread Length 30mm
• Catalog Number: 03.900.351
• Company Name: CROSSROADS EXTREMITY SYSTEMS
• Labeler DUNS: 058864308
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-23
• Public Version: 1
• Public Version Date: 2024-03-04
• Public Version Status: New
• Public Device Record Key: 2cb2f252-3da5-4e7b-91ef-f819c6997112

Device Description

Compression Wire 1.6mm for 2.0/2.5/3.0 Plates, Thread Length 30mm

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
66934	Orthopaedic intraoperative positioning pin, reusable	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810112596236	GS1