FDA 510(k)

SixFix™ 六足式固定器および変形分析・矯正ソフトウェア（DACS）

K番号: K190069 · 2019-05-14

決定日2019-05-14

製品コードKTT

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead De, LLC. It received FDA 510(k) clearance on 2019-05-14 under 510(k) number K190069. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device that received FDA 510(k) clearance on 2019-05-14. The listed applicant is Arrowhead De, LLC. The 510(k) number is K190069.

When did SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) receive FDA 510(k) clearance?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) received FDA 510(k) clearance on 2019-05-14, under 510(k) number K190069.

Who is the listed applicant for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

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

What is the FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

The FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is KTT.

申請者としてArrowhead De, LLCを記載するその他の記録

K200123SixFix® Hexapod Fixatorのアクセサリー K162032Arrowhead ミニ-レールフィクサー

公式ソース

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