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FDA 510(k)

變形分析及校正軟體（DACS）及儀器設備

K 號：K180539 · 2018-08-13

申請人Arrowhead Medical Device Technologies, LLC
決定日期2018-08-13
產品代碼OSN
諮詢委員會或
決定相當於

器材摘要

Deformity Analysis and Correction Software (DACS) and Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead Medical Device Technologies, LLC. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K180539. The device is classified under product code OSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Deformity Analysis and Correction Software (DACS) and Instrumentation?

Deformity Analysis and Correction Software (DACS) and Instrumentation is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Arrowhead Medical Device Technologies, LLC. The 510(k) number is K180539.

When did Deformity Analysis and Correction Software (DACS) and Instrumentation receive FDA 510(k) clearance?

Deformity Analysis and Correction Software (DACS) and Instrumentation received FDA 510(k) clearance on 2018-08-13, under 510(k) number K180539.

Who is the listed applicant for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA 510(k) record lists Arrowhead Medical Device Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation is OSN.

相關臨床試驗

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：OSN）

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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