FDA 510(k)

CorticaLINK脊椎融合平台

K 號：K160722 · 2016-07-07

決定日期2016-07-07

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

CorticaLINK Spinal Fusion Platform is the device name listed in this FDA 510(k) record. The listed applicant is Facetlink Dba Linkspine. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K160722. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CorticaLINK Spinal Fusion Platform?

CorticaLINK Spinal Fusion Platform is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Facetlink Dba Linkspine. The 510(k) number is K160722.

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

CorticaLINK Spinal Fusion Platform received FDA 510(k) clearance on 2016-07-07, under 510(k) number K160722.

Who is the listed applicant for CorticaLINK Spinal Fusion Platform?

The FDA 510(k) record lists Facetlink Dba Linkspine 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.

其他以 Facetlink Dba Linkspine 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K162693脊椎鏈結合平台

相關器械（代碼：NKB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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