VyLink™

Basic Information

• Brand Name: VyLink™
• Primary DI: 00840283400841
• Version / Model: 04-XS-6075-TI-N
• Company Name: VY SPINE LLC
• Labeler DUNS: 049592888
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-16
• Public Version: 3
• Public Version Date: 2026-03-12
• Public Version Status: Update
• Public Device Record Key: 6573b148-f7e5-4eb2-9248-de3ed4756b17

Device Description

X-Link, Single, 6.0x75mm, Ti 6Al-4V

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: 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
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	888.3050	2
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840283400841	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213750	000