FDA 510(k)

TriALTIS Spine System

K-Number: K243249 · 2025-01-17

Decision Date2025-01-17

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TriALTIS Spine System is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2025-01-17 under approval number K243249. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriALTIS Spine System?

TriALTIS Spine System is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Medos International SARL. The 510(k) number is K243249.

When was TriALTIS Spine System approved by the FDA?

TriALTIS Spine System received FDA 510(k) clearance on 2025-01-17, under approval number K243249.

What company makes TriALTIS Spine System?

TriALTIS Spine System is manufactured by Medos International SARL.

What is the FDA product code for TriALTIS Spine System?

The FDA product code for TriALTIS Spine System is NKB.

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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.