FDA 510(k)

Parcus Synd-EZ SS

K 號：K192964 · 2019-11-22

決定日期2019-11-22

產品代碼MBI

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決定相當於

器材摘要

Parcus Synd-EZ SS is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical, LLC. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192964. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Parcus Synd-EZ SS?

Parcus Synd-EZ SS is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Parcus Medical, LLC. The 510(k) number is K192964.

When did Parcus Synd-EZ SS receive FDA 510(k) clearance?

Parcus Synd-EZ SS received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192964.

Who is the listed applicant for Parcus Synd-EZ SS?

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

What is the FDA product code for Parcus Synd-EZ SS?

The FDA product code for Parcus Synd-EZ SS is MBI.

其他以 Parcus Medical, LLC 為申請人之記錄

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K221502Parcus Synd-EZ SS K221135X-Twist PEEK 識別器 K212739ActiFlip K202662帕克斯钛合金干擾螺釘 K202259Parcus GFS II 及 GFS Mini、GFS 裸機、GFS Ultimate、GFS BTB、ATLAS、Synd-EZ Ti、Actiflip 裸機、Actiflip Cinch、Actiflip Whip 及 GFS Ultimate Hip K201083Parcus V-lox 鈦金屬縫合釘，Parcus Miti 縫合釘

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相關器械（代碼：MBI）

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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