FDA 510(k)

uCerv Flux™-C 3D Porous Titanium Cervical Interbody

K番号: K241396 · 2024-05-23

決定日2024-05-23

製品コードODP

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

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA, Inc.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K241396. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Ulrich Medical USA, Inc.. The 510(k) number is K241396.

When did uCerv Flux™-C 3D Porous Titanium Cervical Interbody receive FDA 510(k) clearance?

uCerv Flux™-C 3D Porous Titanium Cervical Interbody received FDA 510(k) clearance on 2024-05-23, under 510(k) number K241396.

Who is the listed applicant for uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

The FDA 510(k) record lists Ulrich Medical USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uCerv Flux™-C 3D Porous Titanium Cervical Interbody?

The FDA product code for uCerv Flux™-C 3D Porous Titanium Cervical Interbody is ODP.

申請者としてUlrich Medical USA, Inc.を記載するその他の記録

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公式ソース

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