FDA 510(k)

平衡膝關節修復系統骨小梁胫骨針加強器

K 號：K182085 · 2018-10-31

決定日期2018-10-31

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Balanced Knee Revision System Trabecular Tibial Cone Augments is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2018-10-31 under 510(k) number K182085. 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 Balanced Knee Revision System Trabecular Tibial Cone Augments?

Balanced Knee Revision System Trabecular Tibial Cone Augments is a medical device that received FDA 510(k) clearance on 2018-10-31. The listed applicant is Ortho Development Corporation. The 510(k) number is K182085.

When did Balanced Knee Revision System Trabecular Tibial Cone Augments receive FDA 510(k) clearance?

Balanced Knee Revision System Trabecular Tibial Cone Augments received FDA 510(k) clearance on 2018-10-31, under 510(k) number K182085.

Who is the listed applicant for Balanced Knee Revision System Trabecular Tibial Cone Augments?

The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Balanced Knee Revision System Trabecular Tibial Cone Augments?

The FDA product code for Balanced Knee Revision System Trabecular Tibial Cone Augments is JWH.

其他以 Ortho Development Corporation 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：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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