FDA 510(k)

コーブプッティ、オスティオコーブプッティ

K番号: K242273 · 2024-09-25

決定日2024-09-25

製品コードMQV

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

Cove Putty, OsteoCove Putty is the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K242273. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Cove Putty, OsteoCove Putty?

Cove Putty, OsteoCove Putty is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K242273.

When did Cove Putty, OsteoCove Putty receive FDA 510(k) clearance?

Cove Putty, OsteoCove Putty received FDA 510(k) clearance on 2024-09-25, under 510(k) number K242273.

Who is the listed applicant for Cove Putty, OsteoCove Putty?

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

What is the FDA product code for Cove Putty, OsteoCove Putty?

The FDA product code for Cove Putty, OsteoCove Putty is MQV.

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

すべての67件のデバイスを表示 →

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。