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FDA 510(k)

AxTiHA Stand-Alone ALIF System

K-Number: K212967 · 2021-10-15

ApplicantInnovasis, Inc.
Decision Date2021-10-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AxTiHA Stand-Alone ALIF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2021-10-15 under approval number K212967. 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 2021-10-15. It is manufactured by Innovasis, Inc.. The 510(k) number is K212967.

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

AxTiHA Stand-Alone ALIF System received FDA 510(k) clearance on 2021-10-15, under approval number K212967.

What company makes AxTiHA Stand-Alone ALIF System?

AxTiHA Stand-Alone ALIF System is manufactured by Innovasis, Inc..

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

View on FDA Database →

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

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