FDA 510(k)

GEO骨釘系統

K 號：K202817 · 2020-10-22

決定日期2020-10-22

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

GEO Bone Screw 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 2020-10-22 under 510(k) number K202817. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the GEO Bone Screw System?

GEO Bone Screw System is a medical device that received FDA 510(k) clearance on 2020-10-22. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K202817.

When did GEO Bone Screw System receive FDA 510(k) clearance?

GEO Bone Screw System received FDA 510(k) clearance on 2020-10-22, under 510(k) number K202817.

Who is the listed applicant for GEO Bone Screw 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 Bone Screw System?

The FDA product code for GEO Bone Screw System is HWC. This falls under the Cardiovascular category.

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：HWC）

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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