FDA 510(k)

ADI 頸椎間融合設備

K 號：K191812 · 2019-10-24

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

決定日期2019-10-24

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

ADI Cervical Interbody Fusion Device 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 2019-10-24 under 510(k) number K191812. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ADI Cervical Interbody Fusion Device?

ADI Cervical Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Additive Device, Inc. (Adi) D/B/A Restor3D. The 510(k) number is K191812.

When did ADI Cervical Interbody Fusion Device receive FDA 510(k) clearance?

ADI Cervical Interbody Fusion Device received FDA 510(k) clearance on 2019-10-24, under 510(k) number K191812.

Who is the listed applicant for ADI Cervical Interbody Fusion Device?

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 Cervical Interbody Fusion Device?

The FDA product code for ADI Cervical Interbody Fusion Device is ODP.

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

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相關器械（代碼：ODP）

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