FDA 510(k)

UNiD Patient specific 3D printed TLIF cage

Número K: K190092 · 2019-05-08

Data da decisão2019-05-08

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

UNiD Patient specific 3D printed TLIF cage is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2019-05-08 under 510(k) number K190092. 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 UNiD Patient specific 3D printed TLIF cage?

UNiD Patient specific 3D printed TLIF cage is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Medicrea International SA. The 510(k) number is K190092.

When did UNiD Patient specific 3D printed TLIF cage receive FDA 510(k) clearance?

UNiD Patient specific 3D printed TLIF cage received FDA 510(k) clearance on 2019-05-08, under 510(k) number K190092.

Who is the listed applicant for UNiD Patient specific 3D printed TLIF cage?

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

What is the FDA product code for UNiD Patient specific 3D printed TLIF cage?

The FDA product code for UNiD Patient specific 3D printed TLIF cage is MAX.

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Fonte oficial

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