FDA 510(k)

Vy Spine VyLam Laminoplasty System

K-Number: K232471 · 2023-10-10

Decision Date2023-10-10

Product CodeNQW

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Vy Spine VyLam Laminoplasty System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2023-10-10 under approval number K232471. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vy Spine VyLam Laminoplasty System?

Vy Spine VyLam Laminoplasty System is a medical device that received FDA 510(k) clearance on 2023-10-10. It is manufactured by Vy Spine, LLC. The 510(k) number is K232471.

When was Vy Spine VyLam Laminoplasty System approved by the FDA?

Vy Spine VyLam Laminoplasty System received FDA 510(k) clearance on 2023-10-10, under approval number K232471.

What company makes Vy Spine VyLam Laminoplasty System?

Vy Spine VyLam Laminoplasty System is manufactured by Vy Spine, LLC.

What is the FDA product code for Vy Spine VyLam Laminoplasty System?

The FDA product code for Vy Spine VyLam Laminoplasty System is NQW.

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Related Devices (Code: NQW)

K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) K171413HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. K181717Life Spine Laminoplasty SystemLife Spine, Inc. K173215Choice Spine Laminoplasty Fixation SystemChoicespine, LP K191927Hinged Laminoplasty SystemLife Spine, Inc.

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.