FDA 510(k)

精準螺絲

K 號：K160385 · 2016-07-27

決定日期2016-07-27

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

Precision Screw is the device name listed in this FDA 510(k) record. The listed applicant is Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160385. 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 Precision Screw?

Precision Screw is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Cryptych Pty, Ltd.. The 510(k) number is K160385.

When did Precision Screw receive FDA 510(k) clearance?

Precision Screw received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160385.

Who is the listed applicant for Precision Screw?

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

What is the FDA product code for Precision Screw?

The FDA product code for Precision Screw is OLO.

其他以 Cryptych Pty, Ltd. 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。

K200705Nurochek系統

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。