FDA 510(k)

伊科奈奇™ I-Hip™

K 號：K160266 · 2016-04-08

決定日期2016-04-08

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

ICONACY(TM) I-Hip(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Iconacy Orthopedic Implants, LLC. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K160266. 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 ICONACY(TM) I-Hip(TM)?

ICONACY(TM) I-Hip(TM) is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Iconacy Orthopedic Implants, LLC. The 510(k) number is K160266.

When did ICONACY(TM) I-Hip(TM) receive FDA 510(k) clearance?

ICONACY(TM) I-Hip(TM) received FDA 510(k) clearance on 2016-04-08, under 510(k) number K160266.

Who is the listed applicant for ICONACY(TM) I-Hip(TM)?

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

What is the FDA product code for ICONACY(TM) I-Hip(TM)?

The FDA product code for ICONACY(TM) I-Hip(TM) is LPH.

其他以 Iconacy Orthopedic Implants, LLC 為申請人之記錄

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K151307伊科纳奇™ I-Hip™

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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