FDA 510(k)

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K 號：K212853 · 2021-11-05

決定日期2021-11-05

產品代碼OVE

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決定相當於

器材摘要

Cervical Stand-Alone System is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine, LLC. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K212853. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cervical Stand-Alone System?

Cervical Stand-Alone System is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Eminent Spine, LLC. The 510(k) number is K212853.

When did Cervical Stand-Alone System receive FDA 510(k) clearance?

Cervical Stand-Alone System received FDA 510(k) clearance on 2021-11-05, under 510(k) number K212853.

Who is the listed applicant for Cervical Stand-Alone System?

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

What is the FDA product code for Cervical Stand-Alone System?

The FDA product code for Cervical Stand-Alone System is OVE.

其他以 Eminent Spine, LLC 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：OVE）

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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