FDA 510(k)

CorticaLINK Spinal Fusion Platform

Número K: K173484 · 2017-12-11

Data da decisão2017-12-11

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CorticaLINK Spinal Fusion Platform is the device name listed in this FDA 510(k) record. The listed applicant is Linkspine, Inc.. It received FDA 510(k) clearance on 2017-12-11 under 510(k) number K173484. 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 CorticaLINK Spinal Fusion Platform?

CorticaLINK Spinal Fusion Platform is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Linkspine, Inc.. The 510(k) number is K173484.

When did CorticaLINK Spinal Fusion Platform receive FDA 510(k) clearance?

CorticaLINK Spinal Fusion Platform received FDA 510(k) clearance on 2017-12-11, under 510(k) number K173484.

Who is the listed applicant for CorticaLINK Spinal Fusion Platform?

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

What is the FDA product code for CorticaLINK Spinal Fusion Platform?

The FDA product code for CorticaLINK Spinal Fusion Platform is NKB.

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