FDA 510(k)

RTS 小型MTP植入系統

K 號：K173491 · 2018-02-23

決定日期2018-02-23

產品代碼KWH

諮詢委員會或

決定相當於

器材摘要

RTS Lesser MTP Implant System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2018-02-23 under 510(k) number K173491. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the RTS Lesser MTP Implant System?

RTS Lesser MTP Implant System is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is In2bones USA, LLC. The 510(k) number is K173491.

When did RTS Lesser MTP Implant System receive FDA 510(k) clearance?

RTS Lesser MTP Implant System received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173491.

Who is the listed applicant for RTS Lesser MTP Implant System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RTS Lesser MTP Implant System?

The FDA product code for RTS Lesser MTP Implant System is KWH.

其他以 In2bones USA, 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。

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相關器械（代碼：KWH）

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。

K191966新普系統Brm Extremities K190136Fusion Silastic 系統Fusion Orthopedics, LLC K153609RTS柔軟1 MPJ植入物配以耳環In2bones USA, LLC

官方來源

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