FDA 510(k)

Brainlab 兼容 K2M 選向儀器

K 號：K181890 · 2018-11-09

申請人K2m

決定日期2018-11-09

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

Brainlab Compatible K2M Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is K2m. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K181890. 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 Brainlab Compatible K2M Navigation Instruments?

Brainlab Compatible K2M Navigation Instruments is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is K2m. The 510(k) number is K181890.

When did Brainlab Compatible K2M Navigation Instruments receive FDA 510(k) clearance?

Brainlab Compatible K2M Navigation Instruments received FDA 510(k) clearance on 2018-11-09, under 510(k) number K181890.

Who is the listed applicant for Brainlab Compatible K2M Navigation Instruments?

The FDA 510(k) record lists K2m as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brainlab Compatible K2M Navigation Instruments?

The FDA product code for Brainlab Compatible K2M Navigation Instruments is OLO.

其他以 K2m 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。

K182182YUKON脊椎系統 K172941CASCADIA 間隙系統 K171556K2M導航儀器 K173508埃佛勒斯脊椎系統 K171704CAPRI 胸椎切除籠架系統 K171321K2M導航儀器

查看所有 13 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。