FDA 510(k)

Nanovis脊椎間融合系統及Forticore®

K 號：K161485 · 2016-09-06

決定日期2016-09-06

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Nanovis Intervertebral Body Fusion System and Forticore(R) is the device name listed in this FDA 510(k) record. The listed applicant is Nanovis, LLC. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161485. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nanovis Intervertebral Body Fusion System and Forticore(R)?

Nanovis Intervertebral Body Fusion System and Forticore(R) is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Nanovis, LLC. The 510(k) number is K161485.

When did Nanovis Intervertebral Body Fusion System and Forticore(R) receive FDA 510(k) clearance?

Nanovis Intervertebral Body Fusion System and Forticore(R) received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161485.

Who is the listed applicant for Nanovis Intervertebral Body Fusion System and Forticore(R)?

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

What is the FDA product code for Nanovis Intervertebral Body Fusion System and Forticore(R)?

The FDA product code for Nanovis Intervertebral Body Fusion System and Forticore(R) is MAX.

其他以 Nanovis, LLC 為申請人之記錄

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相關器械（代碼：MAX）

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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