FDA 510(k)

フラワー縫合アンカーセット

K番号: K192949 · 2020-10-07

決定日2020-10-07

製品コードMBI

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

Flower Suture Anchor Set is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K192949. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Flower Suture Anchor Set?

Flower Suture Anchor Set is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K192949.

When did Flower Suture Anchor Set receive FDA 510(k) clearance?

Flower Suture Anchor Set received FDA 510(k) clearance on 2020-10-07, under 510(k) number K192949.

Who is the listed applicant for Flower Suture Anchor Set?

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

What is the FDA product code for Flower Suture Anchor Set?

The FDA product code for Flower Suture Anchor Set is MBI.

申請者としてFlower Orthopedics Corporationを記載するその他の記録

K170687フラワー骨釘セット

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