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FDA 510(k)

Navigated Anterolateral Disc Prep Instruments

K-Number: K192336 · 2019-11-22

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2019-11-22
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigated Anterolateral Disc Prep Instruments is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K192336. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigated Anterolateral Disc Prep Instruments?

Navigated Anterolateral Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K192336.

When was Navigated Anterolateral Disc Prep Instruments approved by the FDA?

Navigated Anterolateral Disc Prep Instruments received FDA 510(k) clearance on 2019-11-22, under approval number K192336.

What company makes Navigated Anterolateral Disc Prep Instruments?

Navigated Anterolateral Disc Prep Instruments is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for Navigated Anterolateral Disc Prep Instruments?

The FDA product code for Navigated Anterolateral Disc Prep Instruments is OLO.

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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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