FDA 510(k)

SeaSpine WaveForm C インターボディシステム

K番号: K212904 · 2021-12-14

決定日2021-12-14

製品コードOVE

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

SeaSpine WaveForm C Interbody System 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 2021-12-14 under 510(k) number K212904. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SeaSpine WaveForm C Interbody System?

SeaSpine WaveForm C Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K212904.

When did SeaSpine WaveForm C Interbody System receive FDA 510(k) clearance?

SeaSpine WaveForm C Interbody System received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212904.

Who is the listed applicant for SeaSpine WaveForm C Interbody System?

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 SeaSpine WaveForm C Interbody System?

The FDA product code for SeaSpine WaveForm C Interbody System is OVE.

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。