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FDA 510(k)

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System

K-Number: K201614 · 2020-07-15

ApplicantInnovasis, Inc.
Decision Date2020-07-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2020-07-15 under approval number K201614. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2020-07-15. It is manufactured by Innovasis, Inc.. The 510(k) number is K201614.

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

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System received FDA 510(k) clearance on 2020-07-15, under approval number K201614.

What company makes TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

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

What is the FDA product code for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

The FDA product code for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System is MAX.

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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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