FDA 510(k)

AltiVate Reverse® Glenoid

K 號：K252141 · 2025-08-05

決定日期2025-08-05

產品代碼PHX

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決定相當於

器材摘要

AltiVate Reverse® Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2025-08-05 under 510(k) number K252141. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AltiVate Reverse® Glenoid?

AltiVate Reverse® Glenoid is a medical device that received FDA 510(k) clearance on 2025-08-05. The listed applicant is Encore Medical L.P.. The 510(k) number is K252141.

When did AltiVate Reverse® Glenoid receive FDA 510(k) clearance?

AltiVate Reverse® Glenoid received FDA 510(k) clearance on 2025-08-05, under 510(k) number K252141.

Who is the listed applicant for AltiVate Reverse® Glenoid?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AltiVate Reverse® Glenoid?

The FDA product code for AltiVate Reverse® Glenoid is PHX.

其他以 Encore Medical L.P. 為申請人之記錄

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K252567AltiVate Reverse® ADLC Glenosphere K252974EMPOWR 適合膝 K251833EMPOWR 髋臼內襯擴充器®K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ 髓內插件)K251241EMPOWR Revision Knee™（EMPOWR Revision Knee™ 對稱 TT 筒）K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System

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相關器械（代碼：PHX）

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。

K260556Veritas肩部系統Restor3D K261683Augment 偏心儀器系統Zimmer, Inc.K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反覆蓋擴充件Medacta International, SA K253992Veritas逆向全肩關節系統Restor3D K252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

官方來源

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