FDA 510(k)

依賴腰椎IBF系統

K 號：K173283 · 2018-01-19

決定日期2018-01-19

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Reliance Lumbar IBF 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 2018-01-19 under 510(k) number K173283. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reliance Lumbar IBF System?

Reliance Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Reliance Medical Systems, LLC. The 510(k) number is K173283.

When did Reliance Lumbar IBF System receive FDA 510(k) clearance?

Reliance Lumbar IBF System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173283.

Who is the listed applicant for Reliance Lumbar IBF 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 Lumbar IBF System?

The FDA product code for Reliance Lumbar IBF System is MAX.

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。

K202266依賴式頸椎IBF系統 K210874依賴脊椎螺釘系統 K183049依賴腰椎IBF系統 K173102依賴式頸椎IBF系統 K172489依賴式頸椎IBF系統 K162066依賴脊椎螺釘系統

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相關器械（代碼：MAX）

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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