FDA 510(k)

齊默 Virage OCT 腰椎固定系統

K 號：K153631 · 2016-02-16

決定日期2016-02-16

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Zimmer Virage OCT Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine, Inc.. It received FDA 510(k) clearance on 2016-02-16 under 510(k) number K153631. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zimmer Virage OCT Spinal Fixation System?

Zimmer Virage OCT Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-02-16. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K153631.

When did Zimmer Virage OCT Spinal Fixation System receive FDA 510(k) clearance?

Zimmer Virage OCT Spinal Fixation System received FDA 510(k) clearance on 2016-02-16, under 510(k) number K153631.

Who is the listed applicant for Zimmer Virage OCT Spinal Fixation System?

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

What is the FDA product code for Zimmer Virage OCT Spinal Fixation System?

The FDA product code for Zimmer Virage OCT Spinal Fixation System is NKG.

相關器械（代碼：NKG）

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器材摘要

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相關臨床試驗

相關器械（代碼：NKG）

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