FDA 510(k)

GEO FirstFUSE 首次 MTP 聯接關節融合板系統

K 號：K210534 · 2021-03-26

決定日期2021-03-26

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Gramercy Extremity Orthopedics, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210534. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K210534.

When did GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System receive FDA 510(k) clearance?

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210534.

Who is the listed applicant for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

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

What is the FDA product code for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System?

The FDA product code for GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is HRS.

其他以 Gramercy Extremity Orthopedics, 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：HRS）

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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