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510(k) K193559

Device
NextAR TKA Platform
Applicant
Medacta Inernational SA
510(k) number
K193559
Product code
PBF  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-10
Date received
2019-12-23
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
No

Applicant Contact#

Contact
Stefano Baj
Address
Strada Regina Castel San Pietro (Ch) CH CH-6874 CH-6874

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PBF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252064MedCAD® AccuStride™ SystemMedcad2026-03-27
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

Legacy Summary#

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FDA Review#

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