FDA 510(k)

OIC 髓內釘系統

K 號：K181184 · 2018-07-27

決定日期2018-07-27

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

OIC Intramedullary Nail System is the device name listed in this FDA 510(k) record. The listed applicant is The Orthopaedic Implant Company. It received FDA 510(k) clearance on 2018-07-27 under 510(k) number K181184. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OIC Intramedullary Nail System?

OIC Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2018-07-27. The listed applicant is The Orthopaedic Implant Company. The 510(k) number is K181184.

When did OIC Intramedullary Nail System receive FDA 510(k) clearance?

OIC Intramedullary Nail System received FDA 510(k) clearance on 2018-07-27, under 510(k) number K181184.

Who is the listed applicant for OIC Intramedullary Nail System?

The FDA 510(k) record lists The Orthopaedic Implant Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OIC Intramedullary Nail System?

The FDA product code for OIC Intramedullary Nail System is HSB.

其他以 The Orthopaedic Implant Company 為申請人之記錄

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相關器械（代碼：HSB）

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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