FDA 510(k)

My3D® Personalized Pelvic Reconstruction

Número K: K212815 · 2022-07-06

Data da decisão2022-07-06

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

My3D® Personalized Pelvic Reconstruction is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2022-07-06 under 510(k) number K212815. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the My3D® Personalized Pelvic Reconstruction?

My3D® Personalized Pelvic Reconstruction is a medical device that received FDA 510(k) clearance on 2022-07-06. The listed applicant is Onkos Surgical. The 510(k) number is K212815.

When did My3D® Personalized Pelvic Reconstruction receive FDA 510(k) clearance?

My3D® Personalized Pelvic Reconstruction received FDA 510(k) clearance on 2022-07-06, under 510(k) number K212815.

Who is the listed applicant for My3D® Personalized Pelvic Reconstruction?

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

What is the FDA product code for My3D® Personalized Pelvic Reconstruction?

The FDA product code for My3D® Personalized Pelvic Reconstruction is LPH.

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Fonte oficial

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