FDA.report

510(k) K250394

Device
Fine TTO™
Applicant
Bodycad Laboratories, Inc.
510(k) number
K250394
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-21
Date received
2025-02-12
Regulation
888.3030
Classification name
Orthopaedic Surgical Planning And Instrument Guides
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Nadine Adia
Address
2035 Rue Du Haut-Bord Quebec CA G1N4R7 G1N4R7

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PBF

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K242603MyPAO SA guidesMedacta International S.A.2025-11-19
K251709MedCAD® AccuStride™ SystemMedcad2025-11-04
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K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.2025-06-25
K241811MedCAD® AccuStride™ SystemMedcad2025-03-13
K243912Newclip Patient-matched instrumentation non sterile PSINewclip Technics2025-02-13
K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics2024-11-07
K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.2024-03-18
K240066Fine Osteotomy™Bodycad Laboratories, Inc.2024-02-09
K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics2023-10-25
K223421MedCAD AccuPlan Orthopedics SystemMedcad2023-09-20
K231314Fine Osteotomy™Bodycad Laboratories, Inc.2023-06-02
K220706MyPAO GuidesMedacta International S.A.2023-05-30