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FDA 510(k)

綜合®可轉換關節盂 - Vivacit-E 緩沖層

K 號：K211729 · 2021-11-04

申請人Biomet Manufacturing Corp
決定日期2021-11-04
產品代碼PHX
諮詢委員會或
決定相當於

器材摘要

Comprehensive® Convertible Glenoid - Vivacit-E Liner is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K211729. 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 Comprehensive® Convertible Glenoid - Vivacit-E Liner?

Comprehensive® Convertible Glenoid - Vivacit-E Liner is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K211729.

When did Comprehensive® Convertible Glenoid - Vivacit-E Liner receive FDA 510(k) clearance?

Comprehensive® Convertible Glenoid - Vivacit-E Liner received FDA 510(k) clearance on 2021-11-04, under 510(k) number K211729.

Who is the listed applicant for Comprehensive® Convertible Glenoid - Vivacit-E Liner?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comprehensive® Convertible Glenoid - Vivacit-E Liner?

The FDA product code for Comprehensive® Convertible Glenoid - Vivacit-E Liner is PHX.

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 Biomet Manufacturing Corp 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。

K230540患者專屬規劃解決方案™ 3D 骨頭模型K214001綜合®肩關節系統，綜合®逆轉肩關節系統K202232全面儲存庫重建系統K193038全面肩部系統K182516全面纳米無柄肩部設備K181611全面逆向肩關節系統

查看所有 15 項裝置 →

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Restor3DK261683Augment 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, SAK253992Veritas逆向全肩關節系統Restor3DK252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

官方來源

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