FDA 510(k)

VeriFixx™ 小骨植入體

K 號：K202777 · 2020-11-17

決定日期2020-11-17

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

VeriFixx™ Small Bone Implant is the device name listed in this FDA 510(k) record. The listed applicant is Armis Biopharma, Inc.. It received FDA 510(k) clearance on 2020-11-17 under 510(k) number K202777. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VeriFixx™ Small Bone Implant?

VeriFixx™ Small Bone Implant is a medical device that received FDA 510(k) clearance on 2020-11-17. The listed applicant is Armis Biopharma, Inc.. The 510(k) number is K202777.

When did VeriFixx™ Small Bone Implant receive FDA 510(k) clearance?

VeriFixx™ Small Bone Implant received FDA 510(k) clearance on 2020-11-17, under 510(k) number K202777.

Who is the listed applicant for VeriFixx™ Small Bone Implant?

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

What is the FDA product code for VeriFixx™ Small Bone Implant?

The FDA product code for VeriFixx™ Small Bone Implant is HTY.

其他以 Armis Biopharma, Inc. 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。

K220759Armis VeriCyn 疤痕清潔

相關器械（代碼：HTY）

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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官方來源

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