FDA 510(k)

ATTUNE® Total Knee System; ATTUNE® Revision Sleeve LPS™ Femoral Adaptors

K 號：K253197 · 2025-11-19

決定日期2025-11-19

產品代碼JWH

諮詢委員會或

決定相當於

器材摘要

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K253197. 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 ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors?

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Depuy Ireland UC. The 510(k) number is K253197.

When did ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors receive FDA 510(k) clearance?

ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors received FDA 510(k) clearance on 2025-11-19, under 510(k) number K253197.

Who is the listed applicant for ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors?

The FDA product code for ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors is JWH.

其他以 Depuy Ireland UC 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。

K260480VELYS™ 運動輔助解決方案 K261458ATTUNE Total Knee System; ATTUNE Cementless Knee System K260536Prostalac 髋關節系統，SmartSet V+G雙抗生素骨水泥 K253624INHANCE™ 預後肩關節系統 K253551VELOS™ 髋關節導航系統 K251292RECLAIM單塊式修復股骨柄

查看所有 50 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。