FDA 510(k)

Medline ReNewal 再生處理 Stryker 外固定設備

K 號：K163028 · 2016-12-28

申請人Surgical Instrument Service and Savings, Inc.

決定日期2016-12-28

產品代碼JEC

諮詢委員會或

決定相當於

器材摘要

Medline ReNewal Reprocessed Stryker External Fixation Devices is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K163028. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed Stryker External Fixation Devices?

Medline ReNewal Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K163028.

When did Medline ReNewal Reprocessed Stryker External Fixation Devices receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-12-28, under 510(k) number K163028.

Who is the listed applicant for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices is JEC.

其他以 Surgical Instrument Service and Savings, Inc. 為申請人之記錄

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相關器械（代碼：JEC）

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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