FDA 510(k)

ナノバ・スクリューイン・サutures Anchor、ナノバ・プッシュイン・サutures Anchor

K番号: K163672 · 2017-05-05

決定日2017-05-05

製品コードMAI

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

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K163672. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K163672.

When did Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor receive FDA 510(k) clearance?

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor received FDA 510(k) clearance on 2017-05-05, under 510(k) number K163672.

Who is the listed applicant for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

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

What is the FDA product code for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor?

The FDA product code for Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor is MAI.

申請者としてNanova Biomaterials, Inc.を記載するその他の記録

K172977Nanova 2 ステップエッチングおよび洗浄デンタルアダヒブ，Nanova エッチングガル K171330ノヴァナ・シールант K161174ノヴァナインターフェアンススクリュー K151943ヴァス-Q-クリップ

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