FDA 510(k)

GAP ENDO-EXO 髓腔系統

K 號：K160545 · 2016-11-23

決定日期2016-11-23

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

GAP ENDO-EXO MEDULLARY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pega Medical, Inc.. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K160545. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GAP ENDO-EXO MEDULLARY SYSTEM?

GAP ENDO-EXO MEDULLARY SYSTEM is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Pega Medical, Inc.. The 510(k) number is K160545.

When did GAP ENDO-EXO MEDULLARY SYSTEM receive FDA 510(k) clearance?

GAP ENDO-EXO MEDULLARY SYSTEM received FDA 510(k) clearance on 2016-11-23, under 510(k) number K160545.

Who is the listed applicant for GAP ENDO-EXO MEDULLARY SYSTEM?

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

What is the FDA product code for GAP ENDO-EXO MEDULLARY SYSTEM?

The FDA product code for GAP ENDO-EXO MEDULLARY SYSTEM is HSB.

其他以 Pega Medical, Inc. 為申請人之記錄

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相關器械（代碼：HSB）

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