FDA 510(k)

フラワー骨釘セット

K番号: K170687 · 2017-06-06

決定日2017-06-06

製品コードHWC

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 Bone Screw 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 2017-06-06 under 510(k) number K170687. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Flower Bone Screw Set?

Flower Bone Screw Set is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Flower Orthopedics Corporation. The 510(k) number is K170687.

When did Flower Bone Screw Set receive FDA 510(k) clearance?

Flower Bone Screw Set received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170687.

Who is the listed applicant for Flower Bone Screw 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 Bone Screw Set?

The FDA product code for Flower Bone Screw Set is HWC. This falls under the Cardiovascular category.

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

K192949フラワー縫合アンカーセット

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