FDA 510(k)

ARIX 肘關節系統

K 號：K201656 · 2020-09-15

決定日期2020-09-15

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ARIX Elbow System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K201656. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARIX Elbow System?

ARIX Elbow System is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Jeil Medical Corporation. The 510(k) number is K201656.

When did ARIX Elbow System receive FDA 510(k) clearance?

ARIX Elbow System received FDA 510(k) clearance on 2020-09-15, under 510(k) number K201656.

Who is the listed applicant for ARIX Elbow System?

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

What is the FDA product code for ARIX Elbow System?

The FDA product code for ARIX Elbow System is HRS.

其他以 Jeil Medical Corporation 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。

K252246萊福特MMF系統 K252826ARIX 髋骨釘系統 K251431修復-C PEEK ACIF SA 系統 K243973修復-L PEEK PLIF 及 T-PLIF 系統 K242751ARIX 胸骨條系統 K242247ARIX 髋骨釘系統

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相關器械（代碼：HRS）

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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