FDA 510(k)

地幔釘系統

K 號：K182212 · 2019-01-11

決定日期2019-01-11

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

Geo Staple 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 2019-01-11 under 510(k) number K182212. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Geo Staple System?

Geo Staple System is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Gramercy Extremity Orthopedics, LLC. The 510(k) number is K182212.

When did Geo Staple System receive FDA 510(k) clearance?

Geo Staple System received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182212.

Who is the listed applicant for Geo Staple 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 Staple System?

The FDA product code for Geo Staple System is JDR.

其他以 Gramercy Extremity Orthopedics, LLC 為申請人之記錄

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