VyBrate VBR System
K-Number: K253158 · 2026-01-07
ApplicantVy Spine, LLC
Decision Date2026-01-07
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VyBrate VBR System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2026-01-07 under approval number K253158. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VyBrate VBR System?
VyBrate VBR System is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by Vy Spine, LLC. The 510(k) number is K253158.
When was VyBrate VBR System approved by the FDA?
VyBrate VBR System received FDA 510(k) clearance on 2026-01-07, under approval number K253158.
What company makes VyBrate VBR System?
VyBrate VBR System is manufactured by Vy Spine, LLC.
What is the FDA product code for VyBrate VBR System?
The FDA product code for VyBrate VBR System is MQP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.