FDA 510(k)

Phantom® Hindfoot TTC/TC Nail System

K 號：K253591 · 2026-03-05

決定日期2026-03-05

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Phantom® Hindfoot TTC/TC Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28, Inc.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) number K253591. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Phantom® Hindfoot TTC/TC Nail System?

Phantom® Hindfoot TTC/TC Nail System is a medical device that received FDA 510(k) clearance on 2026-03-05. The listed applicant is Paragon 28, Inc.. The 510(k) number is K253591.

When did Phantom® Hindfoot TTC/TC Nail System receive FDA 510(k) clearance?

Phantom® Hindfoot TTC/TC Nail System received FDA 510(k) clearance on 2026-03-05, under 510(k) number K253591.

Who is the listed applicant for Phantom® Hindfoot TTC/TC Nail System?

FDA 510(k) 記錄將 Paragon 28, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Phantom® Hindfoot TTC/TC Nail System?

The FDA product code for Phantom® Hindfoot TTC/TC Nail System is HSB.

其他以 Paragon 28, Inc. 為申請人之記錄

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相關器械（代碼：HSB）

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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