FDA 510(k)

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System

Número K: K201614 · 2020-07-15

Data da decisão2020-07-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Innovasis, Inc.. The 510(k) number is K201614.

When did TxTiHA IBF System, AxTiHA Stand-Alone ALIF System receive FDA 510(k) clearance?

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

Who is the listed applicant for TxTiHA IBF System, AxTiHA Stand-Alone ALIF System?

The FDA 510(k) record lists Innovasis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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