FDA 510(k)

Initia全髋關節系統 & BIOCERAM AZUL(R) 頭

K 號：K160895 · 2016-11-01

決定日期2016-11-01

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Corporation. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K160895. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Kyocera Medical Corporation. The 510(k) number is K160895.

When did Initia Total Hip System & BIOCERAM AZUL(R) HEAD receive FDA 510(k) clearance?

Initia Total Hip System & BIOCERAM AZUL(R) HEAD received FDA 510(k) clearance on 2016-11-01, under 510(k) number K160895.

Who is the listed applicant for Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

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

What is the FDA product code for Initia Total Hip System & BIOCERAM AZUL(R) HEAD?

The FDA product code for Initia Total Hip System & BIOCERAM AZUL(R) HEAD is LZO.

相關器械（代碼：LZO）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LZO）

官方來源