FDA 510(k)

SMR逆向高壓肩關節系統

K 號：K243826 · 2025-07-03

決定日期2025-07-03

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

SMR Reverse HP Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) number K243826. 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 SMR Reverse HP Shoulder System?

SMR Reverse HP Shoulder System is a medical device that received FDA 510(k) clearance on 2025-07-03. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K243826.

When did SMR Reverse HP Shoulder System receive FDA 510(k) clearance?

SMR Reverse HP Shoulder System received FDA 510(k) clearance on 2025-07-03, under 510(k) number K243826.

Who is the listed applicant for SMR Reverse HP Shoulder System?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMR Reverse HP Shoulder System?

The FDA product code for SMR Reverse HP Shoulder System is PHX.

其他以 Lima Corporate S.P.A. 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。

K252352SMR肩關節系統；PRIMA關節盂系統；PRIMA肱骨系統 K251718ArTT 增強與支撐及骨釘 K250980Physica 系統（Physica CR 多孔股骨组件）K243615物理多孔股骨组件 K234011AMF TT Cones K233712PRIMA 肱骨系統；PRIMA TT 閃輪

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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

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