FDA 510(k)

CarboClear® 子宮頸板システム

K番号: K200883 · 2020-06-04

決定日2020-06-04

製品コードKWQ

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

CarboClear® Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2020-06-04 under 510(k) number K200883. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the CarboClear® Cervical Plate System?

CarboClear® Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K200883.

When did CarboClear® Cervical Plate System receive FDA 510(k) clearance?

CarboClear® Cervical Plate System received FDA 510(k) clearance on 2020-06-04, under 510(k) number K200883.

Who is the listed applicant for CarboClear® Cervical Plate System?

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

What is the FDA product code for CarboClear® Cervical Plate System?

The FDA product code for CarboClear® Cervical Plate System is KWQ.

申請者としてCarboFix Orthopedics , Ltd.を記載するその他の記録

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