FDA 510(k)

PoreStar 患者專屬植入體

K 號：K171037 · 2017-12-27

決定日期2017-12-27

產品代碼JOF

諮詢委員會中文(台灣): 此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。公司名稱：[公司名稱] 產品名稱：[產品名稱]

決定相當於

器材摘要

PoreStar Patient Specific Implant is the device name listed in this FDA 510(k) record. The listed applicant is Anatomics Pty, Ltd.. It received FDA 510(k) clearance on 2017-12-27 under 510(k) number K171037. The device is classified under product code JOF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PoreStar Patient Specific Implant?

PoreStar Patient Specific Implant is a medical device that received FDA 510(k) clearance on 2017-12-27. The listed applicant is Anatomics Pty, Ltd.. The 510(k) number is K171037.

When did PoreStar Patient Specific Implant receive FDA 510(k) clearance?

PoreStar Patient Specific Implant received FDA 510(k) clearance on 2017-12-27, under 510(k) number K171037.

Who is the listed applicant for PoreStar Patient Specific Implant?

The FDA 510(k) record lists Anatomics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PoreStar Patient Specific Implant?

The FDA product code for PoreStar Patient Specific Implant is JOF.

其他以 Anatomics Pty, Ltd. 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。

K200532星孔

相關器械（代碼：JOF）

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。

K200532星孔Anatomics Pty, Ltd.

官方來源

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