FDA 510(k)

Cadence 腳踝壓力測量系統

K 號：K243174 · 2024-10-25

決定日期2024-10-25

產品代碼OYK

諮詢委員會或

決定相當於

器材摘要

Cadence Ankle PSI System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems, Inc.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K243174. The device is classified under product code OYK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cadence Ankle PSI System?

Cadence Ankle PSI System is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is 3D Systems, Inc.. The 510(k) number is K243174.

When did Cadence Ankle PSI System receive FDA 510(k) clearance?

Cadence Ankle PSI System received FDA 510(k) clearance on 2024-10-25, under 510(k) number K243174.

Who is the listed applicant for Cadence Ankle PSI System?

The FDA 510(k) record lists 3D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cadence Ankle PSI System?

The FDA product code for Cadence Ankle PSI System is OYK.

其他以 3D Systems, Inc. 為申請人之記錄

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。

K261826VSP系統（鈦金顎板牙橋）K250711VSP骨科系統 K243173Salto Talaris 腓骨踝壓力系統 K241148Salto Talaris 腓骨踝壓力系統 K241326Cadence 腳踝壓力測量系統 K231834VSP PEEK 頭蓋內植物

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相關器械（代碼：OYK）

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。

K243173Salto Talaris 腓骨踝壓力系統3D Systems, Inc.K241148Salto Talaris 腓骨踝壓力系統3D Systems, Inc.K241326Cadence 腳踝壓力測量系統3D Systems, Inc.K231585Vantage PSI 系統3D Systems, Inc.K223326Axiom PSR系統Restor3D K193432Vantage PSI 系統3D Systems

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