FDA 510(k)

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems

K 號：K161992 · 2016-09-22

決定日期2016-09-22

產品代碼JXG

諮詢委員會NE

決定Substantially Equivalent

器材摘要

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-09-22 under 510(k) number K161992. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems?

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K161992.

When did Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems receive FDA 510(k) clearance?

Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161992.

Who is the listed applicant for Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems?

The FDA product code for Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems is JXG.

其他以 Integra LifeSciences Corporation 為申請人之記錄

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相關器械（代碼：JXG）

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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