FDA 510(k)

GPS頸椎間隔器

K 號：K210890 · 2021-04-23

決定日期2021-04-23

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

GPS Cervical Spacers is the device name listed in this FDA 510(k) record. The listed applicant is G Surgical, LLC. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K210890. 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 GPS Cervical Spacers?

GPS Cervical Spacers is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is G Surgical, LLC. The 510(k) number is K210890.

When did GPS Cervical Spacers receive FDA 510(k) clearance?

GPS Cervical Spacers received FDA 510(k) clearance on 2021-04-23, under 510(k) number K210890.

Who is the listed applicant for GPS Cervical Spacers?

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

What is the FDA product code for GPS Cervical Spacers?

The FDA product code for GPS Cervical Spacers is ODP.

其他以 G Surgical, LLC 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：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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