FDA 510(k)

PASS XS Spinal System

Número K: K160640 · 2016-09-23

Data da decisão2016-09-23

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PASS XS Spinal System 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 2016-09-23 under 510(k) number K160640. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PASS XS Spinal System?

PASS XS Spinal System is a medical device that received FDA 510(k) clearance on 2016-09-23. The listed applicant is Medicrea International SA. The 510(k) number is K160640.

When did PASS XS Spinal System receive FDA 510(k) clearance?

PASS XS Spinal System received FDA 510(k) clearance on 2016-09-23, under 510(k) number K160640.

Who is the listed applicant for PASS XS Spinal System?

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 PASS XS Spinal System?

The FDA product code for PASS XS Spinal System is NKB.

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Fonte oficial

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