FDA 510(k)

自由初級PCK

K 號：K192148 · 2019-09-05

決定日期2019-09-05

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

Freedom Primary PCK is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K192148. 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 Freedom Primary PCK?

Freedom Primary PCK is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K192148.

When did Freedom Primary PCK receive FDA 510(k) clearance?

Freedom Primary PCK received FDA 510(k) clearance on 2019-09-05, under 510(k) number K192148.

Who is the listed applicant for Freedom Primary PCK?

FDA 510(k) 記錄將 Maxx Orthopedics, Inc. 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 Freedom Primary PCK?

The FDA product code for Freedom Primary PCK is JWH.

其他以 Maxx Orthopedics, 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。

K261563自由全膝系統（E-Poly 股骨內襯）K261609自由部分膝關節系統 K253171Libertas 縮窄短 (TS) 未固定股骨柄 (Libertas TS 柄)K252777自由骨顯隆起植入物（骨顯隆起針）K253314自由無限™ 全膝系統 K253144Freedom® 全膝系統 – Titan PCK 零件

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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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