FDA 510(k)

LxHA PEEK Lateral IBF System

Número K: K190684 · 2019-06-17

Data da decisão2019-06-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LxHA PEEK Lateral IBF 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 2019-06-17 under 510(k) number K190684. 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 LxHA PEEK Lateral IBF System?

LxHA PEEK Lateral IBF System is a medical device that received FDA 510(k) clearance on 2019-06-17. The listed applicant is Innovasis, Inc.. The 510(k) number is K190684.

When did LxHA PEEK Lateral IBF System receive FDA 510(k) clearance?

LxHA PEEK Lateral IBF System received FDA 510(k) clearance on 2019-06-17, under 510(k) number K190684.

Who is the listed applicant for LxHA PEEK Lateral IBF 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 LxHA PEEK Lateral IBF System?

The FDA product code for LxHA PEEK Lateral IBF System is MAX.

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Fonte oficial

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