FDA 510(k)

Atlas Spine Rebar (Ti) 空間器系統

K 號：K202302 · 2020-10-30

決定日期2020-10-30

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Atlas Spine Rebar (Ti) Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Spine, Inc.. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K202302. 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 Atlas Spine Rebar (Ti) Spacer System?

Atlas Spine Rebar (Ti) Spacer System is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Atlas Spine, Inc.. The 510(k) number is K202302.

When did Atlas Spine Rebar (Ti) Spacer System receive FDA 510(k) clearance?

Atlas Spine Rebar (Ti) Spacer System received FDA 510(k) clearance on 2020-10-30, under 510(k) number K202302.

Who is the listed applicant for Atlas Spine Rebar (Ti) Spacer System?

FDA 510(k) 記錄將 Atlas Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Atlas Spine Rebar (Ti) Spacer System?

The FDA product code for Atlas Spine Rebar (Ti) Spacer System is ODP.

其他以 Atlas Spine, Inc. 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：ODP）

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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