FDA 510(k)

Px PEEK IBF 系統，Px HA PEEK IBF 系統，TxHA PEEK IBF 系統

K 號：K180078 · 2018-04-17

決定日期2018-04-17

產品代碼MAX

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器材摘要

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180078. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System?

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Innovasis, Inc.. The 510(k) number is K180078.

When did Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System receive FDA 510(k) clearance?

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180078.

Who is the listed applicant for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System?

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

What is the FDA product code for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System?

The FDA product code for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is MAX.

其他以 Innovasis, Inc. 為申請人之記錄

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相關器械（代碼：MAX）

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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