FDA 510(k)

Newclip 患者匹配儀器非無菌 PSI

K 號：K243912 · 2025-02-13

決定日期2025-02-13

產品代碼PBF

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器材摘要

Newclip Patient-matched instrumentation non sterile PSI is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K243912. 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 Newclip Patient-matched instrumentation non sterile PSI?

Newclip Patient-matched instrumentation non sterile PSI is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Newclip Technics. The 510(k) number is K243912.

When did Newclip Patient-matched instrumentation non sterile PSI receive FDA 510(k) clearance?

Newclip Patient-matched instrumentation non sterile PSI received FDA 510(k) clearance on 2025-02-13, under 510(k) number K243912.

Who is the listed applicant for Newclip Patient-matched instrumentation non sterile PSI?

FDA 510(k) 記錄將 Newclip Technics 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Newclip Patient-matched instrumentation non sterile PSI?

The FDA product code for Newclip Patient-matched instrumentation non sterile PSI is PBF.

其他以 Newclip Technics 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。

K261511Xpert 頸部 K261191Alians Elbow S K261038Xpert PFP K253906Xpert 手機械設備 K250767Newclip 患者匹配儀器非無菌 PSI K250155Xpert膝

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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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