FDA 510(k)

RESPONSE™脊椎系統，RESPONSE™ 4.5/5.0脊椎系統，RESPONSE™ 5.5/6.0脊椎系統

K 號：K193100 · 2020-03-24

決定日期2020-03-24

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine 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 2020-03-24 under 510(k) number K193100. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System?

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K193100.

When did RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System receive FDA 510(k) clearance?

RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193100.

Who is the listed applicant for RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine 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 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System?

The FDA product code for RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System is NKB.

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

查看所有 26 項裝置 →

相關器械（代碼：NKB）

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。

K252139肯特羅斯賓 Viktr-MIS® 椎板螺釘系統Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ 假骨植入系統SI-BONE, Inc.K262091FRAXION脊椎固定系統Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 後固定系統搭配NanoACTIV表面技術；RIVA® 髋骨結合固定釘搭配NanoACTIV表面技術Xenix Medical K262828KHEIRON®脊椎固定系統，包括客製化K-RODS.M.A.I.O K260362QUATTRO脊椎系統（開放配置）；QUATTRO-GADGET脊椎系統（MIS配置）MANTIZ Co., Ltd.

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。