FDA 510(k)

INHANCE肩關節系統可轉換盂蓋插件，INHANCE可轉換盂蓋

K 號：K230831 · 2023-11-13

決定日期2023-11-13

產品代碼MBF

諮詢委員會或

決定相當於

器材摘要

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2023-11-13 under 510(k) number K230831. 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 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Depuy Ireland UC. The 510(k) number is K230831.

When did INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid receive FDA 510(k) clearance?

INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid received FDA 510(k) clearance on 2023-11-13, under 510(k) number K230831.

Who is the listed applicant for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid?

The FDA product code for INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid is MBF.

其他以 Depuy Ireland UC 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。

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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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