FDA 510(k)

S-線

K 號：K152662 · 2016-03-09

決定日期2016-03-09

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

S-Wire is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Resources, Inc.. It received FDA 510(k) clearance on 2016-03-09 under 510(k) number K152662. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the S-Wire?

S-Wire is a medical device that received FDA 510(k) clearance on 2016-03-09. The listed applicant is Spinal Resources, Inc.. The 510(k) number is K152662.

When did S-Wire receive FDA 510(k) clearance?

S-Wire received FDA 510(k) clearance on 2016-03-09, under 510(k) number K152662.

Who is the listed applicant for S-Wire?

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

What is the FDA product code for S-Wire?

The FDA product code for S-Wire is HTY.

其他以 Spinal Resources, Inc. 為申請人之記錄

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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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