FDA 510(k)

帕克斯钛合金干擾螺釘

K 號：K202662 · 2021-02-22

決定日期2021-02-22

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Parcus Titanium Interference Screws 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 2021-02-22 under 510(k) number K202662. 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 Titanium Interference Screws?

Parcus Titanium Interference Screws is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Parcus Medical, LLC. The 510(k) number is K202662.

When did Parcus Titanium Interference Screws receive FDA 510(k) clearance?

Parcus Titanium Interference Screws received FDA 510(k) clearance on 2021-02-22, under 510(k) number K202662.

Who is the listed applicant for Parcus Titanium Interference Screws?

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 Titanium Interference Screws?

The FDA product code for Parcus Titanium Interference Screws is MBI.

其他以 Parcus Medical, 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。

K221502Parcus Synd-EZ SS K221135X-Twist PEEK 識別器 K212739ActiFlip 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 K193295Parcus Knotless PEEK及PEEK CF 推入縫合釘

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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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

官方來源

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