FDA 510(k)

VMA™ 系統版本 3.0

K 號：K172327 · 2017-08-25

決定日期2017-08-25

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

VMA™ System version 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Kinematics, Inc.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K172327. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VMA™ System version 3.0?

VMA™ System version 3.0 is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Ortho Kinematics, Inc.. The 510(k) number is K172327.

When did VMA™ System version 3.0 receive FDA 510(k) clearance?

VMA™ System version 3.0 received FDA 510(k) clearance on 2017-08-25, under 510(k) number K172327.

Who is the listed applicant for VMA™ System version 3.0?

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

What is the FDA product code for VMA™ System version 3.0?

The FDA product code for VMA™ System version 3.0 is LLZ.

其他以 Ortho Kinematics, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

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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