FDA 510(k)

精準脊椎導航儀器設備

K 號：K181606 · 2019-09-27

決定日期2019-09-27

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Precision Spine Navigation Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K181606. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Precision Spine Navigation Instrumentation?

Precision Spine Navigation Instrumentation is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Precision Spine, Inc.. The 510(k) number is K181606.

When did Precision Spine Navigation Instrumentation receive FDA 510(k) clearance?

Precision Spine Navigation Instrumentation received FDA 510(k) clearance on 2019-09-27, under 510(k) number K181606.

Who is the listed applicant for Precision Spine Navigation Instrumentation?

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

What is the FDA product code for Precision Spine Navigation Instrumentation?

The FDA product code for Precision Spine Navigation Instrumentation is OLO.

其他以 Precision Spine, Inc. 為申請人之記錄

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相關器械（代碼：OLO）

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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