FDA 510(k)

範圍（丹麥山和梅薩）脊柱系統

K 號：K181119 · 2018-06-26

決定日期2018-06-26

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Range (Denali and Mesa) Spinal Systems is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K181119. 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 Range (Denali and Mesa) Spinal Systems?

Range (Denali and Mesa) Spinal Systems is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is K2m, Inc.. The 510(k) number is K181119.

When did Range (Denali and Mesa) Spinal Systems receive FDA 510(k) clearance?

Range (Denali and Mesa) Spinal Systems received FDA 510(k) clearance on 2018-06-26, under 510(k) number K181119.

Who is the listed applicant for Range (Denali and Mesa) Spinal Systems?

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

What is the FDA product code for Range (Denali and Mesa) Spinal Systems?

The FDA product code for Range (Denali and Mesa) Spinal Systems is NKB.

其他以 K2m, 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。

K260546脊椎工具 K253545伏爾坎脊椎系統 K252873間隙植入器 K211320CAPRI 胸椎切除籠架系統 K202528針筒式電動驅動器附件 K201006K2M導航儀器

查看所有 27 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。