FDA 510(k)

駕駛軌道系統

K 號：K220809 · 2022-04-08

決定日期2022-04-08

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

Drive Rail System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K220809. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Drive Rail System?

Drive Rail System is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K220809.

When did Drive Rail System receive FDA 510(k) clearance?

Drive Rail System received FDA 510(k) clearance on 2022-04-08, under 510(k) number K220809.

Who is the listed applicant for Drive Rail System?

FDA 510(k) 記錄將 OrthoPediatrics Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Drive Rail System?

The FDA product code for Drive Rail System is KTT.

其他以 OrthoPediatrics Corp. 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。

K261345兒童釘針平台髋骨 K260323OrthoPediatrics® 鎖定中空刀片板系統 K252600兒童植板平台 I 小型-迷你 K251362PediFlex™ 強韌指甲系統 K243963兒童植板平台髋 K250623兒童釘針平台道骨兒童釘針平台股骨

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相關器械（代碼：KTT）

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。

K254087MAXFRAME AUTOSTRUT™ 內建藍牙多軸校正系統Synthes (USA) Products, LLC K260900DYNEX® 外固定系統Vilex, LLC K260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean Global K253613猴環外環固定系統Paragon 28, Inc.K253202霍夫曼LRF系統Stryker GmbH

官方來源

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