FDA 510(k)

VSP® 骨科系統

K 號：K211244 · 2021-11-10

決定日期2021-11-10

產品代碼PBF

諮詢委員會或

決定相當於

器材摘要

VSP® Orthopedics System is the device name listed in this FDA 510(k) record. The listed applicant is 3D Systems. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K211244. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VSP® Orthopedics System?

VSP® Orthopedics System is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is 3D Systems. The 510(k) number is K211244.

When did VSP® Orthopedics System receive FDA 510(k) clearance?

VSP® Orthopedics System received FDA 510(k) clearance on 2021-11-10, under 510(k) number K211244.

Who is the listed applicant for VSP® Orthopedics System?

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

What is the FDA product code for VSP® Orthopedics System?

The FDA product code for VSP® Orthopedics System is PBF.

其他以 3D Systems 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。

K214093VSP 靜脈注射劑 K210347VSP系統 K193432Vantage PSI 系統 K192192VSP系統

相關器械（代碼：PBF）

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。

K252064MedCAD® AccuStride™ 系統Medcad K250711VSP骨科系統3D Systems, Inc.K242603MyPAO SA 指導Medacta International S.A.K251709MedCAD® AccuStride™ 系統Medcad K250394精細TTO™Bodycad Laboratories, Inc.K250767Newclip 患者匹配儀器非無菌 PSINewclip Technics

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