VyWasher™

Basic Information

• Brand Name: VyWasher™
• Primary DI: 00840283400377
• Version / Model: 12-SC-45-30-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: 1
• Public Version Date: 2024-08-26
• Public Version Status: New
• Public Device Record Key: 76b558bf-35dc-48d7-b97c-1abf6a4605a0

Device Description

Screw, 4.5x30mm, 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
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64171	Vertebral body bone graft positioning plate	A small, sterile, implantable device intended to be fixed to the anterior surface of an adjacent vertebral body to hold an intervertebral bone graft in place. It is in form of a small metallic plate with screw(s) and is implanted during anterior abdominal open surgery. It is not intended to be weight-bearing and is typically used in conjunction with rigid spinal fixation devices.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840283400377	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K213219	000