FDA 510(k)

KMTI S141 腰椎間融合系統

K 號：K212070 · 2021-08-30

決定日期2021-08-30

產品代碼MAX

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決定相當於

器材摘要

KMTI S141 Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-08-30 under 510(k) number K212070. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KMTI S141 Lumbar Interbody Fusion System?

KMTI S141 Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2021-08-30. The listed applicant is Kyocera Medical Technologies, Inc.. The 510(k) number is K212070.

When did KMTI S141 Lumbar Interbody Fusion System receive FDA 510(k) clearance?

KMTI S141 Lumbar Interbody Fusion System received FDA 510(k) clearance on 2021-08-30, under 510(k) number K212070.

Who is the listed applicant for KMTI S141 Lumbar Interbody Fusion System?

FDA 510(k) 記錄將京瓷醫療技術股份有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for KMTI S141 Lumbar Interbody Fusion System?

The FDA product code for KMTI S141 Lumbar Interbody Fusion System is MAX.

其他以 Kyocera Medical Technologies, 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：MAX）

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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