FDA 510(k)

Impulse Interbody Fusion System

Número K: K201287 · 2020-12-22

Data da decisão2020-12-22

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Impulse Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201287. 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 Impulse Interbody Fusion System?

Impulse Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Degen Medical. The 510(k) number is K201287.

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

Impulse Interbody Fusion System received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201287.

Who is the listed applicant for Impulse Interbody Fusion System?

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

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

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

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Outros registros que listam Degen Medical como candidato(a)

K251829DeGen Medical Patient Specific Implant (PSI) System K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion System K250667DeGen Medical Patient Specific Implant (PSI) System K241077DeGen Medical Patient Specific Implant (PSI) System K231199Solar Lumbar Interbody Fusion System K223418DeGen Impulse AM™ System

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Fonte oficial

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