FDA 510(k)

頸椎脊柱支撐系統-獨立型（CSTS-SA）

K 號：K190870 · 2019-08-12

決定日期2019-08-12

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Cervical Spinal Truss System-Stand Alone (CSTS-SA) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2019-08-12 under 510(k) number K190870. 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 Spinal Truss System-Stand Alone (CSTS-SA)?

Cervical Spinal Truss System-Stand Alone (CSTS-SA) is a medical device that received FDA 510(k) clearance on 2019-08-12. The listed applicant is 4Web, Inc.. The 510(k) number is K190870.

When did Cervical Spinal Truss System-Stand Alone (CSTS-SA) receive FDA 510(k) clearance?

Cervical Spinal Truss System-Stand Alone (CSTS-SA) received FDA 510(k) clearance on 2019-08-12, under 510(k) number K190870.

Who is the listed applicant for Cervical Spinal Truss System-Stand Alone (CSTS-SA)?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cervical Spinal Truss System-Stand Alone (CSTS-SA)?

The FDA product code for Cervical Spinal Truss System-Stand Alone (CSTS-SA) is OVE.

其他以 4Web, Inc. 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。

K253201腰椎脊柱支架系統 - 鋼板解決方案（LSTS-PS）K203065腰椎脊柱支架系統板金解決方案（LSTS-PS）K200002前脊柱支架系統 – 独立型（ASTS-SA）椎間融合設備 K190926鍵節固定系統（HTS）K172294骨切架系統（OTS）K173159頸椎脊柱支撐系統（Cervical Spinal Truss System, CSTS）內固定融合裝置

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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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