FDA 510(k)

iNSitu 全髋關節系統

K 號：K192071 · 2019-08-30

決定日期2019-08-30

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

iNSitu Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Theken Companies, LLC. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K192071. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iNSitu Total Hip System?

iNSitu Total Hip System is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Theken Companies, LLC. The 510(k) number is K192071.

When did iNSitu Total Hip System receive FDA 510(k) clearance?

iNSitu Total Hip System received FDA 510(k) clearance on 2019-08-30, under 510(k) number K192071.

Who is the listed applicant for iNSitu Total Hip System?

The FDA 510(k) record lists Theken Companies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iNSitu Total Hip System?

The FDA product code for iNSitu Total Hip System is LPH.

其他以 Theken Companies, LLC 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。

K191297iNSitu雙極股骨系統 K172501iNSitu 全髋關節系統 K161184iNSitu 全髋關節系統

相關器械（代碼：LPH）

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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