FDA 510(k)

Navigated Spine Instruments

K-Number: K203205 · 2021-03-23

Decision Date2021-03-23

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Navigated Spine Instruments is a medical device manufactured by Stryker Spine. It received FDA 510(k) clearance on 2021-03-23 under approval number K203205. 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 Spine Instruments?

Navigated Spine Instruments is a medical device that received FDA 510(k) clearance on 2021-03-23. It is manufactured by Stryker Spine. The 510(k) number is K203205.

When was Navigated Spine Instruments approved by the FDA?

Navigated Spine Instruments received FDA 510(k) clearance on 2021-03-23, under approval number K203205.

What company makes Navigated Spine Instruments?

Navigated Spine Instruments is manufactured by Stryker Spine.

What is the FDA product code for Navigated Spine Instruments?

The FDA product code for Navigated Spine 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.