FDA 510(k)

平衡膝關節系統 TriMax 多孔股骨組件

K 號：K253161 · 2025-12-19

決定日期2025-12-19

產品代碼MBH

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器材摘要

Balanced Knee System TriMax Porous Femoral Components is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253161. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Balanced Knee System TriMax Porous Femoral Components?

Balanced Knee System TriMax Porous Femoral Components is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Ortho Development Corp.. The 510(k) number is K253161.

When did Balanced Knee System TriMax Porous Femoral Components receive FDA 510(k) clearance?

Balanced Knee System TriMax Porous Femoral Components received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253161.

Who is the listed applicant for Balanced Knee System TriMax Porous Femoral Components?

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

What is the FDA product code for Balanced Knee System TriMax Porous Femoral Components?

The FDA product code for Balanced Knee System TriMax Porous Femoral Components is MBH.

其他以 Ortho Development 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。

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相關器械（代碼：MBH）

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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