Cleared Traditional

VyBrate? VBR System

K253158 · Vy Spine, LLC · Orthopedic
Jan 2026
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K253158 is an FDA 510(k) clearance for the VyBrate? VBR System, a Spinal Vertebral Body Replacement Device (Class II — Special Controls, product code MQP), submitted by Vy Spine, LLC (Bountiful, US). The FDA issued a Cleared decision on January 7, 2026, 103 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K253158 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date January 07, 2026
Days to Decision 103 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQP — Spinal Vertebral Body Replacement Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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