FDA.reportPublic FDA data

510(k) K242263

Device
TECHFIT DISRP® System
Applicant
Techfit Digital Surgery, Inc.
510(k) number
K242263
Product code
DZJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-11
Date received
2024-08-01
Regulation
872.4120
Classification name
Driver, Wire, And Bone Drill, Manual
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Susana Munoz Cuartas
Address
1511 Aviation Center Pkwy. Suite 220h Daytona Beach FL US 32114 32114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZJ#

510(k), Device, Applicant table
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K230276TECHFIT DISRP® SystemTechfit Digital Surgery2023-06-23
K223024MedCAD AccuPlan SystemMedcad2023-03-07
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K212570OsteoPlan SystemOsteomed, LLC2022-02-11
K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.2021-06-28
K193301coDiagnostiXDental Wings GmbH2021-06-21
K210347VSP System3D Systems2021-04-26
K193499DigiGuide SystemProtomed, Inc.2020-11-04
K192282MedCAD® AccuPlan® SystemMedcad2020-10-29
K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch2020-06-09
K192192VSP System3D Systems2020-02-26
K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.2019-03-11