FDA 510(k)

Summit Spine Yellowstone 腰椎間融合系統

K 號：K170572 · 2017-04-26

決定日期2017-04-26

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Summit Spine Yellowstone Lumbar Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Summit Spine. It received FDA 510(k) clearance on 2017-04-26 under 510(k) number K170572. 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 Summit Spine Yellowstone Lumbar Interbody Fusion System?

Summit Spine Yellowstone Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-04-26. The listed applicant is Summit Spine. The 510(k) number is K170572.

When did Summit Spine Yellowstone Lumbar Interbody Fusion System receive FDA 510(k) clearance?

Summit Spine Yellowstone Lumbar Interbody Fusion System received FDA 510(k) clearance on 2017-04-26, under 510(k) number K170572.

Who is the listed applicant for Summit Spine Yellowstone Lumbar Interbody Fusion System?

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

What is the FDA product code for Summit Spine Yellowstone Lumbar Interbody Fusion System?

The FDA product code for Summit Spine Yellowstone Lumbar Interbody Fusion System is MAX.

其他以 Summit Spine 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。

K163494Summit脊椎通道頸椎間融合系統

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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