FDA 510(k)

restor3d TiDAL 腰椎間融合器

K 號：K220523 · 2022-06-17

決定日期2022-06-17

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

restor3d TiDAL Lumbar Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2022-06-17 under 510(k) number K220523. 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 restor3d TiDAL Lumbar Interbody Fusion Device?

restor3d TiDAL Lumbar Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2022-06-17. The listed applicant is Restor3D. The 510(k) number is K220523.

When did restor3d TiDAL Lumbar Interbody Fusion Device receive FDA 510(k) clearance?

restor3d TiDAL Lumbar Interbody Fusion Device received FDA 510(k) clearance on 2022-06-17, under 510(k) number K220523.

Who is the listed applicant for restor3d TiDAL Lumbar Interbody Fusion Device?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for restor3d TiDAL Lumbar Interbody Fusion Device?

The FDA product code for restor3d TiDAL Lumbar Interbody Fusion Device is MAX.

其他以 Restor3D 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。

K260556Veritas肩部系統 K253992Veritas逆向全肩關節系統 K252454金諾斯全腳踝系統 K243643restor3d 過全肩關節置换系統 K242868金諾斯全腳踝系統 K241482金諾斯全腳踝系統

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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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官方來源

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