FDA 510(k)

外科導航先進平台（SNAP）

K 號：K160584 · 2016-06-28

決定日期2016-06-28

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Surgical Navigation Advanced Platform (SNAP) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Theater, LLC. It received FDA 510(k) clearance on 2016-06-28 under 510(k) number K160584. 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 Surgical Navigation Advanced Platform (SNAP)?

Surgical Navigation Advanced Platform (SNAP) is a medical device that received FDA 510(k) clearance on 2016-06-28. The listed applicant is Surgical Theater, LLC. The 510(k) number is K160584.

When did Surgical Navigation Advanced Platform (SNAP) receive FDA 510(k) clearance?

Surgical Navigation Advanced Platform (SNAP) received FDA 510(k) clearance on 2016-06-28, under 510(k) number K160584.

Who is the listed applicant for Surgical Navigation Advanced Platform (SNAP)?

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

What is the FDA product code for Surgical Navigation Advanced Platform (SNAP)?

The FDA product code for Surgical Navigation Advanced Platform (SNAP) is LLZ.

其他以 Surgical Theater, LLC 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。

K170793手術計劃器（SRP）

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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