FDA 510(k)

Renovis S180 邊側腰椎間融合系統

K 號：K181655 · 2018-09-11

決定日期2018-09-11

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Renovis S180 Lateral Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Renovis Surgical Technologies. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K181655. 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 Renovis S180 Lateral Lumbar Interbody Fusion System?

Renovis S180 Lateral Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Renovis Surgical Technologies. The 510(k) number is K181655.

When did Renovis S180 Lateral Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Renovis S180 Lateral Lumbar Interbody Fusion System received FDA 510(k) clearance on 2018-09-11, under 510(k) number K181655.

Who is the listed applicant for Renovis S180 Lateral Lumbar Interbody Fusion System?

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

What is the FDA product code for Renovis S180 Lateral Lumbar Interbody Fusion System?

The FDA product code for Renovis S180 Lateral Lumbar Interbody Fusion System is MAX.

其他以 Renovis Surgical Technologies 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。

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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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