FDA 510(k)

VSP骨科系統

K 號：K190044 · 2019-08-21

決定日期2019-08-21

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, Inc.. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K190044. 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 2019-08-21. The listed applicant is 3D Systems, Inc.. The 510(k) number is K190044.

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

VSP Orthopedics System received FDA 510(k) clearance on 2019-08-21, under 510(k) number K190044.

Who is the listed applicant for VSP Orthopedics 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 VSP Orthopedics System?

The FDA product code for VSP Orthopedics System is PBF.

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 K243174Cadence 腳踝壓力測量系統 K243173Salto Talaris 腓骨踝壓力系統 K241326Cadence 腳踝壓力測量系統 K241148Salto Talaris 腓骨踝壓力系統

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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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