FDA 510(k)

CalcShift™ 足跟骨截骨術系統

K 號：K212979 · 2022-05-20

決定日期2022-05-20

產品代碼HRS

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決定相當於

器材摘要

CalcShift™ Displacement Calcaneal Osteotomy System is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2022-05-20 under 510(k) number K212979. 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 CalcShift™ Displacement Calcaneal Osteotomy System?

CalcShift™ Displacement Calcaneal Osteotomy System is a medical device that received FDA 510(k) clearance on 2022-05-20. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K212979.

When did CalcShift™ Displacement Calcaneal Osteotomy System receive FDA 510(k) clearance?

CalcShift™ Displacement Calcaneal Osteotomy System received FDA 510(k) clearance on 2022-05-20, under 510(k) number K212979.

Who is the listed applicant for CalcShift™ Displacement Calcaneal Osteotomy System?

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

What is the FDA product code for CalcShift™ Displacement Calcaneal Osteotomy System?

The FDA product code for CalcShift™ Displacement Calcaneal Osteotomy System is HRS.

其他以 Nextremity Solutions, Inc. 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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