FDA 510(k)

ADI TiDAL 骨切楔

K 號：K191047 · 2019-11-05

申請人Additive Device, Inc. (Adi) D/B/A Restor3D

決定日期2019-11-05

產品代碼PLF

諮詢委員會或

決定相當於

器材摘要

ADI TiDAL Osteotomy Wedge is the device name listed in this FDA 510(k) record. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K191047. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADI TiDAL Osteotomy Wedge?

ADI TiDAL Osteotomy Wedge is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191047.

When did ADI TiDAL Osteotomy Wedge receive FDA 510(k) clearance?

ADI TiDAL Osteotomy Wedge received FDA 510(k) clearance on 2019-11-05, under 510(k) number K191047.

Who is the listed applicant for ADI TiDAL Osteotomy Wedge?

The FDA 510(k) record lists Additive Device, Inc. (Adi) D/B/A Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADI TiDAL Osteotomy Wedge?

The FDA product code for ADI TiDAL Osteotomy Wedge is PLF.

其他以 Additive Device, Inc. (Adi) D/B/A Restor3D 為申請人之記錄

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K191812ADI 頸椎間融合設備

相關器械（代碼：PLF）

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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