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FDA 510(k)

Zimmer 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）

K 號：K253592 · 2026-04-13

申請人Zimmer, Inc.
決定日期2026-04-13
產品代碼MBF
諮詢委員會或
決定相當於

器材摘要

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K253592. 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 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is Zimmer, Inc.. The 510(k) number is K253592.

When did Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) receive FDA 510(k) clearance?

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) received FDA 510(k) clearance on 2026-04-13, under 510(k) number K253592.

Who is the listed applicant for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

FDA 510(k) 記錄將 Zimmer, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

The FDA product code for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is MBF.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Zimmer, Inc. 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。

K262955OsseoFit無柄肩部系統K261683Augment 偏心儀器系統K260831Z1 髋關節系統K251840齊默® 佩森娜® 適合個人化膝關節系統K260182Avenir® Müller 植入物；Avenir Complete™ 髋關節系統K253566Affixus 逆向股骨釘系統

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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。

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.K230831INHANCE肩關節系統可轉換盂蓋插件，INHANCE可轉換盂蓋Depuy Ireland UC

官方來源

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