FDA 510(k)

ガリレオ脊椎骨代用品装置

K番号: K192145 · 2020-04-21

決定日2020-04-21

製品コードPLR

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

Galileo Vertebral Body Replacement Device is the device name listed in this FDA 510(k) record. The listed applicant is Bright Spine. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K192145. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Galileo Vertebral Body Replacement Device?

Galileo Vertebral Body Replacement Device is a medical device that received FDA 510(k) clearance on 2020-04-21. The listed applicant is Bright Spine. The 510(k) number is K192145.

When did Galileo Vertebral Body Replacement Device receive FDA 510(k) clearance?

Galileo Vertebral Body Replacement Device received FDA 510(k) clearance on 2020-04-21, under 510(k) number K192145.

Who is the listed applicant for Galileo Vertebral Body Replacement Device?

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

What is the FDA product code for Galileo Vertebral Body Replacement Device?

The FDA product code for Galileo Vertebral Body Replacement Device is PLR.

申請者としてBright Spineを記載するその他の記録

K221542ガリレオ脊椎骨代用品装置

公式ソース

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