FDA 510(k)

Erisma® LP 微創手術設備

K 號：K162367 · 2016-10-27

決定日期2016-10-27

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Erisma® LP MIS is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K162367. 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 Erisma® LP MIS?

Erisma® LP MIS is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Clariance, Sas. The 510(k) number is K162367.

When did Erisma® LP MIS receive FDA 510(k) clearance?

Erisma® LP MIS received FDA 510(k) clearance on 2016-10-27, under 510(k) number K162367.

Who is the listed applicant for Erisma® LP MIS?

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

What is the FDA product code for Erisma® LP MIS?

The FDA product code for Erisma® LP MIS is NKB.

其他以 Clariance, Sas 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。

K202032Idys LLIF 3DTi K202956Erisma LP 精準導航儀器 K200920Idys ALIF ZP 3DTi 医療設備規範文本 K192168Idys ALIF ZP 3DTi 医療設備規範文本 K191263Idys ALIF TiVac K183259Idys™ TLIF TiVac

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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

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