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FDA 510(k)

Stealthstation S8 Spine Software v1.3.0

K-Number: K201189 · 2020-05-29

ApplicantMedtronic Navigation, Inc.
Decision Date2020-05-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stealthstation S8 Spine Software v1.3.0 is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2020-05-29 under approval number K201189. 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 Stealthstation S8 Spine Software v1.3.0?

Stealthstation S8 Spine Software v1.3.0 is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K201189.

When was Stealthstation S8 Spine Software v1.3.0 approved by the FDA?

Stealthstation S8 Spine Software v1.3.0 received FDA 510(k) clearance on 2020-05-29, under approval number K201189.

What company makes Stealthstation S8 Spine Software v1.3.0?

Stealthstation S8 Spine Software v1.3.0 is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Stealthstation S8 Spine Software v1.3.0?

The FDA product code for Stealthstation S8 Spine Software v1.3.0 is OLO.

Related Clinical Trials

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Other Devices by Medtronic Navigation, Inc.

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Related Devices (Code: 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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