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FDA 510(k)

AxTiHA® Stand-Alone ALIF System

K-Number: K250603 · 2025-03-24

ApplicantInnovasis
Decision Date2025-03-24
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AxTiHA® Stand-Alone ALIF System is a medical device manufactured by Innovasis. It received FDA 510(k) clearance on 2025-03-24 under approval number K250603. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AxTiHA® Stand-Alone ALIF System?

AxTiHA® Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Innovasis. The 510(k) number is K250603.

When was AxTiHA® Stand-Alone ALIF System approved by the FDA?

AxTiHA® Stand-Alone ALIF System received FDA 510(k) clearance on 2025-03-24, under approval number K250603.

What company makes AxTiHA® Stand-Alone ALIF System?

AxTiHA® Stand-Alone ALIF System is manufactured by Innovasis.

What is the FDA product code for AxTiHA® Stand-Alone ALIF System?

The FDA product code for AxTiHA® Stand-Alone ALIF System is OVD.

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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.

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