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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Vy Spine, LLC. It received FDA 510(k) clearance on 2026-01-07 under 510(k) 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. The listed applicant is Vy Spine, LLC. The 510(k) number is K253158.

When did VyBrate™ VBR System receive FDA 510(k) clearance?

VyBrate™ VBR System received FDA 510(k) clearance on 2026-01-07, under 510(k) number K253158.

Who is the listed applicant for VyBrate™ VBR System?

The FDA 510(k) record lists Vy Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VyBrate™ VBR System?

The FDA product code for VyBrate™ VBR System is MQP.

Other records listing Vy Spine, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura MedicalK231134VerteLoc Spinal SystemSignature Orthopaedics Pty, Ltd.

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.

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