FDA 510(k)

SpineView X-Pac 可擴展腰椎籠架系統

K 號：K160856 · 2016-08-01

決定日期2016-08-01

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

SpineView X-Pac Expandable Lumbar Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Spine View, Inc.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160856. 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 SpineView X-Pac Expandable Lumbar Cage System?

SpineView X-Pac Expandable Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Spine View, Inc.. The 510(k) number is K160856.

When did SpineView X-Pac Expandable Lumbar Cage System receive FDA 510(k) clearance?

SpineView X-Pac Expandable Lumbar Cage System received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160856.

Who is the listed applicant for SpineView X-Pac Expandable Lumbar Cage System?

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

What is the FDA product code for SpineView X-Pac Expandable Lumbar Cage System?

The FDA product code for SpineView X-Pac Expandable Lumbar Cage System is MAX.

其他以 Spine View, 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。

K152539SpineView X-Pac 可擴展腰椎籠架系統

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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