FDA 510(k)

ORTHOLOC 2 配合 3Di 技術的 Pilon 骨折板系統

K 號：K201259 · 2021-01-08

決定日期2021-01-08

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K201259. 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 ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K201259.

When did ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System receive FDA 510(k) clearance?

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System received FDA 510(k) clearance on 2021-01-08, under 510(k) number K201259.

Who is the listed applicant for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?

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

What is the FDA product code for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System?

The FDA product code for ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System is HRS.

其他以 Wrightmedicaltechnologyinc 為申請人之記錄

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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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