FDA 510(k)

TriALTIS Navigation Enabled Instruments

K-Number: K231527 · 2023-09-29

Decision Date2023-09-29

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TriALTIS Navigation Enabled Instruments is a medical device manufactured by Medos International Sàrl. It received FDA 510(k) clearance on 2023-09-29 under approval number K231527. 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 TriALTIS Navigation Enabled Instruments?

TriALTIS Navigation Enabled Instruments is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Medos International Sàrl. The 510(k) number is K231527.

When was TriALTIS Navigation Enabled Instruments approved by the FDA?

TriALTIS Navigation Enabled Instruments received FDA 510(k) clearance on 2023-09-29, under approval number K231527.

What company makes TriALTIS Navigation Enabled Instruments?

TriALTIS Navigation Enabled Instruments is manufactured by Medos International Sàrl.

What is the FDA product code for TriALTIS Navigation Enabled Instruments?

The FDA product code for TriALTIS Navigation Enabled Instruments is OLO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.