FDA 510(k)

全面肩部系統

K 號：K193038 · 2020-10-28

決定日期2020-10-28

產品代碼MBF

諮詢委員會或

決定相當於

器材摘要

Comprehensive Shoulder System 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 2020-10-28 under 510(k) number K193038. 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 Comprehensive Shoulder System?

Comprehensive Shoulder System is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K193038.

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

Comprehensive Shoulder System received FDA 510(k) clearance on 2020-10-28, under 510(k) number K193038.

Who is the listed applicant for Comprehensive Shoulder System?

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 Shoulder System?

The FDA product code for Comprehensive Shoulder System is MBF.

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 K211729綜合®可轉換關節盂 - Vivacit-E 緩沖層 K202232全面儲存庫重建系統 K182516全面纳米無柄肩部設備 K181611全面逆向肩關節系統

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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。

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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