FDA 510(k)

SMR肩關節系統

K 號：K223876 · 2023-02-03

決定日期2023-02-03

產品代碼MBF

諮詢委員會或

決定相當於

器材摘要

SMR 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 2023-02-03 under 510(k) number K223876. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SMR Shoulder System?

SMR Shoulder System is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K223876.

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

SMR Shoulder System received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223876.

Who is the listed applicant for SMR 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 Shoulder System?

The FDA product code for SMR Shoulder System is MBF.

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：MBF）

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。

K253592Zimmer Biomet 反向肩蓋假體（Alliance 肱骨承重環，Identity 肱骨托盤，全面性反向肱骨托盤，全面性反向 32mm 髋球和適配器）Zimmer, Inc.K251098身份修復上臂干Zimmer, Inc.K250848身份肩部系統Zimmer, Inc.K240876身份肩部系統Zimmer, Inc.K233712PRIMA 肱骨系統；PRIMA TT 閃輪Lima Corporate S.P.A.K231099SMR雙模擬盂蓋系統Lima Corporate S.P.A.

官方來源

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