FDA 510(k)

範圍/丹尼利/梅薩脊柱系統

K 號：K171832 · 2017-09-14

決定日期2017-09-14

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Range/Denali/Mesa Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K171832. 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 Range/Denali/Mesa Spinal System?

Range/Denali/Mesa Spinal System is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is K2m, Inc.. The 510(k) number is K171832.

When did Range/Denali/Mesa Spinal System receive FDA 510(k) clearance?

Range/Denali/Mesa Spinal System received FDA 510(k) clearance on 2017-09-14, under 510(k) number K171832.

Who is the listed applicant for Range/Denali/Mesa Spinal System?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Range/Denali/Mesa Spinal System?

The FDA product code for Range/Denali/Mesa Spinal System is NKB.

其他以 K2m, Inc. 為申請人之記錄

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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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