FDA 510(k)

NILE 選擇性固定脊柱系統

K 號：K160208 · 2016-03-18

決定日期2016-03-18

產品代碼OWI

諮詢委員會或

決定相當於

器材摘要

NILE Alternative Fixation 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 2016-03-18 under 510(k) number K160208. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NILE Alternative Fixation Spinal System?

NILE Alternative Fixation Spinal System is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is K2m, Inc.. The 510(k) number is K160208.

When did NILE Alternative Fixation Spinal System receive FDA 510(k) clearance?

NILE Alternative Fixation Spinal System received FDA 510(k) clearance on 2016-03-18, under 510(k) number K160208.

Who is the listed applicant for NILE Alternative Fixation 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 NILE Alternative Fixation Spinal System?

The FDA product code for NILE Alternative Fixation Spinal System is OWI.

其他以 K2m, Inc. 為申請人之記錄

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相關器械（代碼：OWI）

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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