FDA 510(k)

HAtetracell™-C 鈦金屬頸椎內固定系統

K 號：K231899 · 2023-10-17

決定日期2023-10-17

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

HAtetracell™-C Titanium Cervical 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 2023-10-17 under 510(k) number K231899. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAtetracell™-C Titanium Cervical IBF System?

HAtetracell™-C Titanium Cervical IBF System is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Innovasis, Inc.. The 510(k) number is K231899.

When did HAtetracell™-C Titanium Cervical IBF System receive FDA 510(k) clearance?

HAtetracell™-C Titanium Cervical IBF System received FDA 510(k) clearance on 2023-10-17, under 510(k) number K231899.

Who is the listed applicant for HAtetracell™-C Titanium Cervical 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 HAtetracell™-C Titanium Cervical IBF System?

The FDA product code for HAtetracell™-C Titanium Cervical IBF System is ODP.

其他以 Innovasis, 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。

K251073Innovasis導航儀器（Vector G-E導航儀器和Excella G-E導航儀器）K250182Innovasis導航儀器 K241276Vector™脊椎螺釘系統 K223511精確導航儀器 K223510Matrix HA融合多孔頸椎IBF系統 K220875HAcancellous PEEK-C 多孔 HA PEEK 頸椎 IBF 系統

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相關器械（代碼：ODP）

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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官方來源

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