FDA 510(k)

PROW FUSION-L 医療設備規範文本中文翻譯： PROW FUSION-L 医療設備規範文本

K 號：K153665 · 2016-09-15

決定日期2016-09-15

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

PROW FUSION-L is the device name listed in this FDA 510(k) record. The listed applicant is Nlt Spine, Ltd.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K153665. 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 PROW FUSION-L?

PROW FUSION-L is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Nlt Spine, Ltd.. The 510(k) number is K153665.

When did PROW FUSION-L receive FDA 510(k) clearance?

PROW FUSION-L received FDA 510(k) clearance on 2016-09-15, under 510(k) number K153665.

Who is the listed applicant for PROW FUSION-L?

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

What is the FDA product code for PROW FUSION-L?

The FDA product code for PROW FUSION-L is MAX.

其他以 Nlt Spine, Ltd. 為申請人之記錄

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K153786PROW FUSION-V

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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