FDA 510(k)

K2M Growing Spine System

Número K: K161028 · 2016-07-22

Data da decisão2016-07-22

Código do produtoPGM

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

K2M Growing Spine System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2016-07-22 under 510(k) number K161028. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the K2M Growing Spine System?

K2M Growing Spine System is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is K2m, Inc.. The 510(k) number is K161028.

When did K2M Growing Spine System receive FDA 510(k) clearance?

K2M Growing Spine System received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161028.

Who is the listed applicant for K2M Growing Spine System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Growing Spine System?

The FDA product code for K2M Growing Spine System is PGM.

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Fonte oficial

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