FDA.reportPublic FDA data

510(k) K040369

Device
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Applicant
STRYKER INSTRUMENTS
510(k) number
K040369
Product code
DZJ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-04-01
Date received
2004-02-13
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
JEAN W SHEPPARD
Address
4100 E. Milham Ave. Kalamazoo MI US 49001 49001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV2025-02-21
K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.2024-12-11
K231520tmCMF SolutionTechmah Cmf2023-10-02
K230276TECHFIT DISRP® SystemTechfit Digital Surgery2023-06-23
K223024MedCAD AccuPlan SystemMedcad2023-03-07
K220366EmbedMed3D Lifeprints UK , Ltd.2022-09-30
K220648OMF ASP SystemVha Dean2022-08-11
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

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases