FDA 510(k)

AltiVate Reverse® ADLC Glenosphere

K 號：K252567 · 2026-01-15

決定日期2026-01-15

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

AltiVate Reverse® ADLC Glenosphere 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 2026-01-15 under 510(k) number K252567. 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® ADLC Glenosphere?

AltiVate Reverse® ADLC Glenosphere is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Encore Medical L.P.. The 510(k) number is K252567.

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

AltiVate Reverse® ADLC Glenosphere received FDA 510(k) clearance on 2026-01-15, under 510(k) number K252567.

Who is the listed applicant for AltiVate Reverse® ADLC Glenosphere?

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® ADLC Glenosphere?

The FDA product code for AltiVate Reverse® ADLC Glenosphere is PHX.

其他以 Encore Medical L.P. 為申請人之記錄

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K252974EMPOWR 適合膝 K251833EMPOWR 髋臼內襯擴充器®K252141AltiVate Reverse® Glenoid 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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