FDA 510(k)

ストリームライン・ナビゲートド・インストルメンツ

K番号: K200095 · 2020-06-26

申請者Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

決定日2020-06-26

製品コードOLO

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Streamline Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200095. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Streamline Navigated Instruments?

Streamline Navigated Instruments is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K200095.

When did Streamline Navigated Instruments receive FDA 510(k) clearance?

Streamline Navigated Instruments received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200095.

Who is the listed applicant for Streamline Navigated Instruments?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Streamline Navigated Instruments?

The FDA product code for Streamline Navigated Instruments is OLO.

申請者としてPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.を記載するその他の記録

K201497EVOSケーブルシステム K193468トリチウム胸骨板システム K192800ストリームラインTL脊椎固定システム K192718フォーティリンクインターボディフュージョンデバイス（IBF）およびTETRAfuse 3D テクノロジー K190498Fortilink® IBF System with TETRAfuse®3D Technology、以下の設計を含む：Fortilink®-TS IBF System、Fortilink®-L I BF System、Fortilink®-C IBF System K183060CervAlign™ 前頸椎板システム

すべての13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。