FDA 510(k)

Kestrel™ 壳體板系統

K 號：K181063 · 2018-07-13

決定日期2018-07-13

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Kestrel™ Buttress Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K181063. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kestrel™ Buttress Plate System?

Kestrel™ Buttress Plate System is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Innovasis, Inc.. The 510(k) number is K181063.

When did Kestrel™ Buttress Plate System receive FDA 510(k) clearance?

Kestrel™ Buttress Plate System received FDA 510(k) clearance on 2018-07-13, under 510(k) number K181063.

Who is the listed applicant for Kestrel™ Buttress Plate System?

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

What is the FDA product code for Kestrel™ Buttress Plate System?

The FDA product code for Kestrel™ Buttress Plate System is KWQ.

其他以 Innovasis, Inc. 為申請人之記錄

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相關器械（代碼：KWQ）

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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