FDA 510(k)

Invictus Bands System

K-Number: K253615 · 2026-03-25

Decision Date2026-03-25

Product CodeOWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Invictus Bands System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2026-03-25 under approval number K253615. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invictus Bands System?

Invictus Bands System is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K253615.

When was Invictus Bands System approved by the FDA?

Invictus Bands System received FDA 510(k) clearance on 2026-03-25, under approval number K253615.

What company makes Invictus Bands System?

Invictus Bands System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Invictus Bands System?

The FDA product code for Invictus Bands System is OWI.

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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.