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FDA 510(k)

Vy Spine™ VyLam™ Laminoplasty System

K-Number: K232471 · 2023-10-10

ApplicantVy Spine, LLC
Decision Date2023-10-10
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vy Spine™ VyLam™ Laminoplasty 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 2023-10-10 under 510(k) 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. The listed applicant is Vy Spine, LLC. The 510(k) number is K232471.

When did Vy Spine™ VyLam™ Laminoplasty System receive FDA 510(k) clearance?

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

Who is the listed applicant for Vy Spine™ VyLam™ Laminoplasty 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 Vy Spine™ VyLam™ Laminoplasty System?

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

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.

K260697VyPlate™ Anterior Cervical Plate SystemK253432DiversiVy™ Facet Screw SystemK253158VyBrate™ VBR SystemK241783FortiVy™ OsteoVy™ Lumbar IBFK242784Vy Spine™ VyLam™ Laminoplasty SystemK233807LumiVy™ Lumbar IBF System

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Related Devices (Code: NQW)

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.

K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK231232Curiteva Laminoplasty SystemCuriteva, Inc.K212428Centerpiece Plate Fixation SystemMedtronic Sofamor DanekK191927Hinged 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.

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