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FDA 510(k)

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments

K-Number: K163581 · 2017-04-14

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2017-04-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments 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 2017-04-14 under 510(k) number K163581. 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 ELEVATE Inserter, Navigated Disc Prep Instruments?

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K163581.

When did Navigated ELEVATE Inserter, Navigated Disc Prep Instruments receive FDA 510(k) clearance?

Navigated ELEVATE Inserter, Navigated Disc Prep Instruments received FDA 510(k) clearance on 2017-04-14, under 510(k) number K163581.

Who is the listed applicant for Navigated ELEVATE Inserter, Navigated Disc Prep Instruments?

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 Navigated ELEVATE Inserter, Navigated Disc Prep Instruments?

The FDA product code for Navigated ELEVATE Inserter, Navigated 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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