FDA 510(k)

SNUCONE 骨水平植入系統

K 號：K210354 · 2022-07-13

決定日期2022-07-13

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

SNUCONE Bone Level Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Snucone Co., Ltd.. It received FDA 510(k) clearance on 2022-07-13 under 510(k) number K210354. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SNUCONE Bone Level Implant System?

SNUCONE Bone Level Implant System is a medical device that received FDA 510(k) clearance on 2022-07-13. The listed applicant is Snucone Co., Ltd.. The 510(k) number is K210354.

When did SNUCONE Bone Level Implant System receive FDA 510(k) clearance?

SNUCONE Bone Level Implant System received FDA 510(k) clearance on 2022-07-13, under 510(k) number K210354.

Who is the listed applicant for SNUCONE Bone Level Implant System?

The FDA 510(k) record lists Snucone Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNUCONE Bone Level Implant System?

The FDA product code for SNUCONE Bone Level Implant System is DZE.

其他以 Snucone Co., Ltd. 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。

K222792SNUCONE 組織層次植入系統

相關器械（代碼：DZE）

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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