FDA 510(k)

OCT枕頸胸系統 streamline

K 號：K172139 · 2017-08-18

申請人Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

決定日期2017-08-18

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Streamline OCT Occipito-Cervico-Thoracic System 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 2017-08-18 under 510(k) number K172139. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Streamline OCT Occipito-Cervico-Thoracic System?

Streamline OCT Occipito-Cervico-Thoracic System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K172139.

When did Streamline OCT Occipito-Cervico-Thoracic System receive FDA 510(k) clearance?

Streamline OCT Occipito-Cervico-Thoracic System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K172139.

Who is the listed applicant for Streamline OCT Occipito-Cervico-Thoracic System?

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 OCT Occipito-Cervico-Thoracic System?

The FDA product code for Streamline OCT Occipito-Cervico-Thoracic System is NKG.

其他以 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：NKG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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