FDA 510(k)

PRIMA上臂系統及SMR股頭球 Ø42

K 號：K212800 · 2022-02-25

決定日期2022-02-25

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

PRIMA Humeral System and SMR Glenosphere Ø42 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 2022-02-25 under 510(k) number K212800. 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 PRIMA Humeral System and SMR Glenosphere Ø42?

PRIMA Humeral System and SMR Glenosphere Ø42 is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K212800.

When did PRIMA Humeral System and SMR Glenosphere Ø42 receive FDA 510(k) clearance?

PRIMA Humeral System and SMR Glenosphere Ø42 received FDA 510(k) clearance on 2022-02-25, under 510(k) number K212800.

Who is the listed applicant for PRIMA Humeral System and SMR Glenosphere Ø42?

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 PRIMA Humeral System and SMR Glenosphere Ø42?

The FDA product code for PRIMA Humeral System and SMR Glenosphere Ø42 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 K243826SMR逆向高壓肩關節系統 K250980Physica 系統（Physica CR 多孔股骨组件）K243615物理多孔股骨组件 K234011AMF TT Cones

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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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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。