FDA 510(k)

Xenix Medical Sacroiliac Fixation System

K番号: K231829 · 2023-08-15

決定日2023-08-15

製品コードOUR

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

Xenix Medical Sacroiliac Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2023-08-15 under 510(k) number K231829. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Xenix Medical Sacroiliac Fixation System?

Xenix Medical Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2023-08-15. The listed applicant is Ht Medical D.B.A. Xenix Medical. The 510(k) number is K231829.

When did Xenix Medical Sacroiliac Fixation System receive FDA 510(k) clearance?

Xenix Medical Sacroiliac Fixation System received FDA 510(k) clearance on 2023-08-15, under 510(k) number K231829.

Who is the listed applicant for Xenix Medical Sacroiliac Fixation System?

The FDA 510(k) record lists Ht Medical D.B.A. Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenix Medical Sacroiliac Fixation System?

The FDA product code for Xenix Medical Sacroiliac Fixation System is OUR.

申請者としてHt Medical D.B.A. Xenix Medicalを記載するその他の記録

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