The Tether Vertebral Body Tethering System

Basic Information

• Brand Name: The Tether Vertebral Body Tethering System
• Primary DI: 03662663161244
• Version / Model: 203H0012
• Catalog Number: 203H0012
• Company Name: Highridge Medical, LLC
• Labeler DUNS: 119260394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-17
• Public Version: 1
• Public Version Date: 2025-12-25
• Public Version Status: New
• Public Device Record Key: 78be54c2-d3a8-487c-b610-248db71d07a8

Device Description

Vertebral Body Tethering Anchor 12mm

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 Conditional
• 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: 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
65555	Anterior spinal tethering system tether anchor	An implantable component of an anterior spinal tethering system intended to be connected to the top end of a vertebral body screw and anchored into the vertebral body in the treatment of idiopathic scoliosis. It is in the form of a small cylinder, fitted over the screw, with pins inserted in bone to provide stability and a threaded socket for holding the tether using a set screw (not included).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03662663161244	GS1

Customer Contacts

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