FDA 510(k)

PolyLock 鍊接系統

K 號：K202959 · 2020-11-24

決定日期2020-11-24

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

PolyLock Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K202959. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PolyLock Plating System?

PolyLock Plating System is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K202959.

When did PolyLock Plating System receive FDA 510(k) clearance?

PolyLock Plating System received FDA 510(k) clearance on 2020-11-24, under 510(k) number K202959.

Who is the listed applicant for PolyLock Plating System?

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

What is the FDA product code for PolyLock Plating System?

The FDA product code for PolyLock Plating System is HRS.

其他以 Fusion Orthopedics, LLC 為申請人之記錄

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K210159內鎖系統 K193377TopLock 牽引系統 K192323PolyLock 小骨板系統 K190136Fusion Silastic 系統 K182342IntraLock Lapidus 系統 K182684HammerTech™ 固定系統

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相關器械（代碼：HRS）

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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官方來源

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