FDA 510(k)

Klassic 髋骨，多孔，Klassic 靈骨基板，多孔

K 號：K162256 · 2016-10-27

決定日期2016-10-27

產品代碼MBH

諮詢委員會或

決定相當於

器材摘要

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K162256. 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 Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K162256.

When did Klassic Femur, Porous, Klassic Tibial Baseplate, Porous receive FDA 510(k) clearance?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous received FDA 510(k) clearance on 2016-10-27, under 510(k) number K162256.

Who is the listed applicant for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

FDA 510(k) 記錄將 Total Joint Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

The FDA product code for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is MBH.

其他以 Total Joint Orthopedics, 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。

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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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官方來源

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