FDA 510(k)

b-ONE 全膝系統

K 號：K180446 · 2018-10-12

決定日期2018-10-12

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

b-ONE Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180446. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the b-ONE Total Knee System?

b-ONE Total Knee System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K180446.

When did b-ONE Total Knee System receive FDA 510(k) clearance?

b-ONE Total Knee System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180446.

Who is the listed applicant for b-ONE Total Knee System?

FDA 510(k) 記錄將 B-One Ortho, 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 b-ONE Total Knee System?

The FDA product code for b-ONE Total Knee System is JWH.

其他以 B-One Ortho, 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。

K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展 K253357b-ONE®雙極頭 K240528b-ONE® 全髋關節系統 K222431b-ONER MOBIO 全膝系統 K213673b-ONE MOBIO 全膝系統 K212912OneFix 生物複合锚，OneFix 生物複合小锚，OneFix 全縫合锚，OneFix 阻抗螺釘，OneFix 穿刺系統

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相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SA K260063GSPE 分隔器The General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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