FDA 510(k)

Erisma LP 精準導航儀器

K 號：K202956 · 2021-02-26

決定日期2021-02-26

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Erisma LP Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K202956. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Erisma LP Navigated Instruments?

Erisma LP Navigated Instruments is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Clariance, Sas. The 510(k) number is K202956.

When did Erisma LP Navigated Instruments receive FDA 510(k) clearance?

Erisma LP Navigated Instruments received FDA 510(k) clearance on 2021-02-26, under 510(k) number K202956.

Who is the listed applicant for Erisma LP Navigated Instruments?

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 Navigated Instruments?

The FDA product code for Erisma LP Navigated Instruments is OLO.

其他以 Clariance, Sas 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。

K202032Idys LLIF 3DTi 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 K172465Idys™ TLIF 3DTi 金屬板

查看所有 11 項裝置 →

相關器械（代碼：OLO）

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。

K262506Remex脊椎手術導航 - 適用儀器Remex Medical Corp.K261410Navbit MARQ (PRD-001-SUP（仰臥登錄套件），PRD-001-LAT（側臥登錄套件）)Suite 201, National Innovation Centre K261205脊椎藝術導航儀器系統Spineart SA K261024TMINI 微型機器人系統THINK Surgical, Inc.K262121離子-L導航儀器SurGenTec, LLC K261113Op.n™脊椎導航與機械導引Ecential Robotics

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。