FDA 510(k)

正骨按鈕 CL

K 號：K160655 · 2016-06-03

決定日期2016-06-03

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

OrthoButton CL is the device name listed in this FDA 510(k) record. The listed applicant is Riverpoint Medical. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K160655. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OrthoButton CL?

OrthoButton CL is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Riverpoint Medical. The 510(k) number is K160655.

When did OrthoButton CL receive FDA 510(k) clearance?

OrthoButton CL received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160655.

Who is the listed applicant for OrthoButton CL?

FDA 510(k) 記錄將 Riverpoint Medical 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for OrthoButton CL?

The FDA product code for OrthoButton CL is MBI.

其他以 Riverpoint Medical 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。

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相關器械（代碼：MBI）

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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

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