FDA 510(k)

無菌PHALINX槌狀趾系統

K 號：K212996 · 2021-11-16

決定日期2021-11-16

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

Sterile PHALINX Hammertoe System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2021-11-16 under 510(k) number K212996. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile PHALINX Hammertoe System?

Sterile PHALINX Hammertoe System is a medical device that received FDA 510(k) clearance on 2021-11-16. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K212996.

When did Sterile PHALINX Hammertoe System receive FDA 510(k) clearance?

Sterile PHALINX Hammertoe System received FDA 510(k) clearance on 2021-11-16, under 510(k) number K212996.

Who is the listed applicant for Sterile PHALINX Hammertoe 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 Sterile PHALINX Hammertoe System?

The FDA product code for Sterile PHALINX Hammertoe System is HWC. This falls under the Cardiovascular category.

其他以 Wrightmedicaltechnologyinc 為申請人之記錄

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相關器械（代碼：HWC）

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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