FDA 510(k)

精細TTO™

K 號：K250394 · 2025-10-21

決定日期2025-10-21

產品代碼PBF

諮詢委員會或

決定相當於

器材摘要

Fine TTO™ is the device name listed in this FDA 510(k) record. The listed applicant is Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K250394. 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 Fine TTO™?

Fine TTO™ is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Bodycad Laboratories, Inc.. The 510(k) number is K250394.

When did Fine TTO™ receive FDA 510(k) clearance?

Fine TTO™ received FDA 510(k) clearance on 2025-10-21, under 510(k) number K250394.

Who is the listed applicant for Fine TTO™?

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

What is the FDA product code for Fine TTO™?

The FDA product code for Fine TTO™ is PBF.

其他以 Bodycad Laboratories, 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。

K253300精準骨斷術™K250923精準骨斷術™K241356精準骨斷術™K240703精準骨斷術™K240066精準骨斷術™K231314精準骨斷術™

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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 K250767Newclip 患者匹配儀器非無菌 PSINewclip Technics K250921CORIOGRAPH 預術規劃與建模服務Blue Belt Technologies, Inc.

官方來源

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