FDA 510(k)

FlareHawk Interbody Fusion System

Número K: K183184 · 2019-04-03

Data da decisão2019-04-03

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FlareHawk Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Implants, Inc.. It received FDA 510(k) clearance on 2019-04-03 under 510(k) number K183184. 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 FlareHawk Interbody Fusion System?

FlareHawk Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-04-03. The listed applicant is Integrity Implants, Inc.. The 510(k) number is K183184.

When did FlareHawk Interbody Fusion System receive FDA 510(k) clearance?

FlareHawk Interbody Fusion System received FDA 510(k) clearance on 2019-04-03, under 510(k) number K183184.

Who is the listed applicant for FlareHawk Interbody Fusion System?

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

What is the FDA product code for FlareHawk Interbody Fusion System?

The FDA product code for FlareHawk Interbody Fusion System is MAX.

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Outros registros que listam Integrity Implants, Inc. como candidato(a)

K231098LineSider® Spinal System K213355Toro-L Interbody Fusion System K220453FlareHawk Interbody Fusion System K212088Integrity Implants Navigated Instruments K203038Toro-L Interbody Fusion System K203367LineSider™ Spinal System

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Dispositivos Relacionados (Código: MAX)

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Fonte oficial

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