ZAVATION VBR TRIAL

Basic Information

• Brand Name: ZAVATION VBR TRIAL
• Primary DI: 00197157051600
• Version / Model: 02C02019
• Company Name: Zavation LLC
• Labeler DUNS: 069472800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-07
• Public Version: 1
• Public Version Date: 2025-10-15
• Public Version Status: New
• Public Device Record Key: eb025602-949d-4a26-89e8-798943e85ce5

Device Description

VBR TRIAL - 14.5MM X 12MM X 67MM, 7 DEG

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63093	Internal spinal fixation force sensor trial	A copy of a final internal spinal fixation force sensor, typically mounted on a handle, designed to be used to determine availability of adequate space for the fixation of the final temporary sensor used during the implantation procedure of an internal spinal fixation system. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00197157051600	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K202637	000