FDA 510(k)

美國共和國脊柱暗星脊柱系統

K 號：K181495 · 2018-07-25

決定日期2018-07-25

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Republic Spine Dark Star Spinal 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 2018-07-25 under 510(k) number K181495. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Republic Spine Dark Star Spinal System?

Republic Spine Dark Star Spinal System is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is Republic Spine, LLC. The 510(k) number is K181495.

When did Republic Spine Dark Star Spinal System receive FDA 510(k) clearance?

Republic Spine Dark Star Spinal System received FDA 510(k) clearance on 2018-07-25, under 510(k) number K181495.

Who is the listed applicant for Republic Spine Dark Star Spinal 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 Dark Star Spinal System?

The FDA product code for Republic Spine Dark Star Spinal System is NKB.

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。

K223096暗星變形椎板螺釘系統 K212028暗星導航儀器系統 K201420美國共和國脊柱暗星脊柱系統 K190398美國共和國脊椎恢復椎間體融合系統 K190889美國共和國脊椎恢復頸椎間融合系統

相關器械（代碼：NKB）

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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