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FDA 510(k)

Tarsa-Link Stand-Alone Wedge Fixation System

K 號：K161037 · 2016-08-15

申請人Life Spine, Inc.
決定日期2016-08-15
產品代碼HRS
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Tarsa-Link Stand-Alone Wedge Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2016-08-15 under 510(k) number K161037. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tarsa-Link Stand-Alone Wedge Fixation System?

Tarsa-Link Stand-Alone Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is Life Spine, Inc.. The 510(k) number is K161037.

When did Tarsa-Link Stand-Alone Wedge Fixation System receive FDA 510(k) clearance?

Tarsa-Link Stand-Alone Wedge Fixation System received FDA 510(k) clearance on 2016-08-15, under 510(k) number K161037.

Who is the listed applicant for Tarsa-Link Stand-Alone Wedge Fixation System?

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

What is the FDA product code for Tarsa-Link Stand-Alone Wedge Fixation System?

The FDA product code for Tarsa-Link Stand-Alone Wedge Fixation System is HRS.

相關臨床試驗

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其他以 Life Spine, Inc. 為申請人之記錄

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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相關器械（代碼：HRS）

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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