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FDA 510(k)

VERTEX™ Reconstruction System

K-Number: K180851 · 2018-04-18

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2018-04-18
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTEX™ Reconstruction System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-04-18 under 510(k) number K180851. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEX™ Reconstruction System?

VERTEX™ Reconstruction System is a medical device that received FDA 510(k) clearance on 2018-04-18. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K180851.

When did VERTEX™ Reconstruction System receive FDA 510(k) clearance?

VERTEX™ Reconstruction System received FDA 510(k) clearance on 2018-04-18, under 510(k) number K180851.

Who is the listed applicant for VERTEX™ Reconstruction System?

The FDA 510(k) record lists Medtronic Sofamor Danek USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTEX™ Reconstruction System?

The FDA product code for VERTEX™ Reconstruction System is NKG.

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Related Devices (Code: NKG)

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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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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