FDA.report

510(k) K252064

Device
MedCAD® AccuStride™ System
Applicant
Medcad
510(k) number
K252064
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-27
Date received
2025-07-01
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
Brian Buss
Address
501 S 2nd Ave. Suite A-1000 Dallas TX US 75226 75226

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PBF

510(k)DeviceApplicantDecision date
K250711VSP Orthopedics System3D Systems, Inc.2025-12-05
K242603MyPAO SA guidesMedacta International S.A.2025-11-19
K251709MedCAD® AccuStride™ SystemMedcad2025-11-04
K250394Fine TTO™Bodycad Laboratories, Inc.2025-10-21
K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics2025-10-01
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