FDA 510(k)

美國共和國脊椎恢復頸椎間融合系統

K 號：K190889 · 2019-06-19

決定日期2019-06-19

產品代碼ODP

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決定相當於

器材摘要

Republic Spine Restore Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Republic Spine, LLC. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190889. 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 Republic Spine Restore Cervical Interbody Fusion System?

Republic Spine Restore Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Republic Spine, LLC. The 510(k) number is K190889.

When did Republic Spine Restore Cervical Interbody Fusion System receive FDA 510(k) clearance?

Republic Spine Restore Cervical Interbody Fusion System received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190889.

Who is the listed applicant for Republic Spine Restore Cervical Interbody Fusion System?

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

What is the FDA product code for Republic Spine Restore Cervical Interbody Fusion System?

The FDA product code for Republic Spine Restore Cervical Interbody Fusion System is ODP.

其他以 Republic 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：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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