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FDA 510(k)

Normandy VBR System

K-Number: K191423 · 2019-08-06

ApplicantZavation Medical Products, LLC
Decision Date2019-08-06
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Normandy VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K191423. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Normandy VBR System?

Normandy VBR System is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K191423.

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

Normandy VBR System received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191423.

Who is the listed applicant for Normandy VBR System?

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

What is the FDA product code for Normandy VBR System?

The FDA product code for Normandy VBR System is PLR.

Other records listing Zavation Medical Products, LLC as applicant

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Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, 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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