FDA 510(k)

VerteFIT脊椎切除カイジングシステム

K番号: K162133 · 2017-05-16

決定日2017-05-16

製品コードMQP

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

VerteFIT Corpectomy Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2017-05-16 under 510(k) number K162133. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the VerteFIT Corpectomy Cage System?

VerteFIT Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2017-05-16. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K162133.

When did VerteFIT Corpectomy Cage System receive FDA 510(k) clearance?

VerteFIT Corpectomy Cage System received FDA 510(k) clearance on 2017-05-16, under 510(k) number K162133.

Who is the listed applicant for VerteFIT Corpectomy Cage System?

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

What is the FDA product code for VerteFIT Corpectomy Cage System?

The FDA product code for VerteFIT Corpectomy Cage System is MQP.

申請者としてLdr Spine USA, Inc.を記載するその他の記録

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