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 a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-04-18 under approval 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. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K180851.
When was VERTEX Reconstruction System approved by the FDA?
VERTEX Reconstruction System received FDA 510(k) clearance on 2018-04-18, under approval number K180851.
What company makes VERTEX Reconstruction System?
VERTEX Reconstruction System is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for VERTEX Reconstruction System?
The FDA product code for VERTEX Reconstruction System is NKG.
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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.