FDA 510(k)

Sypher間隔系統

K 號：K181337 · 2018-09-18

決定日期2018-09-18

產品代碼MAX

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決定相當於

器材摘要

Sypher Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Biogennix, LLC. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181337. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sypher Spacer System?

Sypher Spacer System is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Biogennix, LLC. The 510(k) number is K181337.

When did Sypher Spacer System receive FDA 510(k) clearance?

Sypher Spacer System received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181337.

Who is the listed applicant for Sypher Spacer System?

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

What is the FDA product code for Sypher Spacer System?

The FDA product code for Sypher Spacer System is MAX.

其他以 Biogennix, 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：MAX）

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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