FDA 510(k)

Axiom PSR系統

K 號：K223326 · 2023-03-30

決定日期2023-03-30

產品代碼OYK

諮詢委員會或

決定相當於

器材摘要

Axiom PSR System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K223326. 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 Axiom PSR System?

Axiom PSR System is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is Restor3D. The 510(k) number is K223326.

When did Axiom PSR System receive FDA 510(k) clearance?

Axiom PSR System received FDA 510(k) clearance on 2023-03-30, under 510(k) number K223326.

Who is the listed applicant for Axiom PSR System?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axiom PSR System?

The FDA product code for Axiom PSR System is OYK.

其他以 Restor3D 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。

K260556Veritas肩部系統 K253992Veritas逆向全肩關節系統 K252454金諾斯全腳踝系統 K243643restor3d 過全肩關節置换系統 K242868金諾斯全腳踝系統 K241482金諾斯全腳踝系統

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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.K243174Cadence 腳踝壓力測量系統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.K193432Vantage PSI 系統3D Systems

官方來源

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