FDA 510(k)

“POINT” 金導機械手臂輔助手術系統

K 號：K220241 · 2022-08-09

決定日期2022-08-09

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

“POINT” Kinguide Robotic-Assisted Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K220241. 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 “POINT” Kinguide Robotic-Assisted Surgical System?

“POINT” Kinguide Robotic-Assisted Surgical System is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Point Robotics MedTech, Inc.. The 510(k) number is K220241.

When did “POINT” Kinguide Robotic-Assisted Surgical System receive FDA 510(k) clearance?

“POINT” Kinguide Robotic-Assisted Surgical System received FDA 510(k) clearance on 2022-08-09, under 510(k) number K220241.

Who is the listed applicant for “POINT” Kinguide Robotic-Assisted Surgical System?

The FDA 510(k) record lists Point Robotics MedTech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for “POINT” Kinguide Robotic-Assisted Surgical System?

The FDA product code for “POINT” Kinguide Robotic-Assisted Surgical System is OLO.

其他以 Point Robotics MedTech, Inc. 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。

K252989“POINT” 金導靈活混合導航系統；DRF 適用配件組 K252755POINT Kinguide 敏捷型機械手臂外科立體定位系統 K241130“POINT” 金導靈活混合導航系統 (PSHF01-000)K230087“POINT” 金導靈活混合導航系統

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

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