FDA 510(k)

ZSFab 腰椎間盤系統

K 號：K221858 · 2022-10-14

決定日期2022-10-14

產品代碼MAX

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決定相當於

器材摘要

ZSFab Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Zsfab, Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221858. 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 ZSFab Lumbar Interbody System?

ZSFab Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Zsfab, Inc.. The 510(k) number is K221858.

When did ZSFab Lumbar Interbody System receive FDA 510(k) clearance?

ZSFab Lumbar Interbody System received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221858.

Who is the listed applicant for ZSFab Lumbar Interbody System?

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

What is the FDA product code for ZSFab Lumbar Interbody System?

The FDA product code for ZSFab Lumbar Interbody System is MAX.

其他以 Zsfab, 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。

K261451ZSAlign脊椎間盤系統 K260549ZSFab 頸椎間融合系統及 ZSFab 腰椎間融合系統 K252610ZSFab 腰椎間盤系統 K232150ZSFab 頸椎間融合系統 K202488ZSFab 頸椎間融合系統

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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官方來源

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