The Tether™

Basic Information

• Brand Name: The Tether™
• Primary DI: 03662663080835
• Version / Model: 240H6003
• Catalog Number: 240H6003
• Company Name: Highridge Medical, LLC
• Labeler DUNS: 119260394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-06
• Public Version: 1
• Public Version Date: 2025-02-14
• Public Version Status: New
• Public Device Record Key: 3c25e120-0bdd-4099-987b-1cc4cca6ac04

Device Description

Tether Reel Tensioner

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
QHP	Vertebral body tethering system	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
65554	Anterior spinal tethering system tether	An implantable, flexible band or cord that is a component of an anterior spinal tethering system and intended to provide restrictive force on one side of the spine to allow growth on the contralateral side, to help achieve straightening of the spine in the treatment of idiopathic scoliosis. It is designed as a longitudinal (intervertebral) component intended to be attached to adjacent vertebral body screws/anchors (not included).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03662663080835	GS1

Customer Contacts

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