FDA 510(k)

SOLO-L

K 號：K220610 · 2022-05-27

決定日期2022-05-27

產品代碼OVD

諮詢委員會或

決定相當於

器材摘要

SOLO-L is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine, Inc.. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K220610. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SOLO-L?

SOLO-L is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Aurora Spine, Inc.. The 510(k) number is K220610.

When did SOLO-L receive FDA 510(k) clearance?

SOLO-L received FDA 510(k) clearance on 2022-05-27, under 510(k) number K220610.

Who is the listed applicant for SOLO-L?

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

What is the FDA product code for SOLO-L?

The FDA product code for SOLO-L is OVD.

其他以 Aurora Spine, Inc. 為申請人之記錄

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相關器械（代碼：OVD）

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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