FDA 510(k)

依賴脊椎螺釘系統

K 號：K210874 · 2021-05-13

決定日期2021-05-13

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Reliance Spinal Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Medical Systems, LLC. It received FDA 510(k) clearance on 2021-05-13 under 510(k) number K210874. 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 Reliance Spinal Screw System?

Reliance Spinal Screw System is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K210874.

When did Reliance Spinal Screw System receive FDA 510(k) clearance?

Reliance Spinal Screw System received FDA 510(k) clearance on 2021-05-13, under 510(k) number K210874.

Who is the listed applicant for Reliance Spinal Screw System?

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

What is the FDA product code for Reliance Spinal Screw System?

The FDA product code for Reliance Spinal Screw System is NKB.

其他以 Reliance Medical Systems, 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：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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官方來源

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