FDA 510(k)

Erisma-LP脊椎固定系統

K 號：K153326 · 2016-03-08

決定日期2016-03-08

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Erisma-LP Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K153326. 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 Erisma-LP Spinal Fixation System?

Erisma-LP Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Clariance, Sas. The 510(k) number is K153326.

When did Erisma-LP Spinal Fixation System receive FDA 510(k) clearance?

Erisma-LP Spinal Fixation System received FDA 510(k) clearance on 2016-03-08, under 510(k) number K153326.

Who is the listed applicant for Erisma-LP Spinal Fixation System?

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

What is the FDA product code for Erisma-LP Spinal Fixation System?

The FDA product code for Erisma-LP Spinal Fixation System is NKB.

其他以 Clariance, Sas 為申請人之記錄

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K202032Idys LLIF 3DTi K202956Erisma LP 精準導航儀器 K200920Idys ALIF ZP 3DTi 医療設備規範文本 K192168Idys ALIF ZP 3DTi 医療設備規範文本 K191263Idys ALIF TiVac K183259Idys™ TLIF TiVac

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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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