FDA 510(k)

CONFIDENCE Spinal Cement System

Número K: K201831 · 2020-08-31

Data da decisão2020-08-31

Código do produtoNDN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CONFIDENCE Spinal Cement System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2020-08-31 under 510(k) number K201831. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CONFIDENCE Spinal Cement System?

CONFIDENCE Spinal Cement System is a medical device that received FDA 510(k) clearance on 2020-08-31. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K201831.

When did CONFIDENCE Spinal Cement System receive FDA 510(k) clearance?

CONFIDENCE Spinal Cement System received FDA 510(k) clearance on 2020-08-31, under 510(k) number K201831.

Who is the listed applicant for CONFIDENCE Spinal Cement System?

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

What is the FDA product code for CONFIDENCE Spinal Cement System?

The FDA product code for CONFIDENCE Spinal Cement System is NDN.

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