FDA 510(k)

自訂條件

K 號：K162633 · 2017-07-24

申請人Implant Direct Sybron Manufacturing, LLC

決定日期2017-07-24

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Custom Bars is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K162633. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Custom Bars?

Custom Bars is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K162633.

When did Custom Bars receive FDA 510(k) clearance?

Custom Bars received FDA 510(k) clearance on 2017-07-24, under 510(k) number K162633.

Who is the listed applicant for Custom Bars?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custom Bars?

The FDA product code for Custom Bars is NHA.

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