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Data / Medical devices / United States / Medical Modeling - A 3D Systems Company

Medical Modeling - A 3D Systems Company: FDA-registered device maker in Littleton, CO, United States, 16 510(k) clearances

Medical Modeling - A 3D Systems Company is registered with the FDA (registration 1724955) in Littleton, CO, United States. It lists 23 device types. The FDA files 16 510(k) clearances under its listings, the newest dated October 25, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Medical Modeling - A 3D Systems Company
FDA registration number
1724955
FEI number
3003142829
Address
5381 South Alkire Circle, Littleton, CO, United States, 80127
Owner or operator
3D Systems, Inc. (9052197)
Roles
Contract manufacturer, Manufacturer
First device listed
July 19, 2002
Registered through
2027
Brand names listed
3D Printed Nasal Swab, 3D Systems Surgical Mask, AccuDental Anatomical Model, AccuView Anatomical Model, ArthroView Anatomical Model, CCSP Bolus, CCSP Orthopedics, Cadence Ankle PSI System and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Manufactureraccessdata.fda.gov
Ankle Arthroplasty Implantation SystemOYK2Contract manufacturer, Manufactureraccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Manufactureraccessdata.fda.gov
Block, Beam-Shaping, Radiation TherapyIXI2Manufactureraccessdata.fda.gov
Cranial Surgical Planning And Instrument GuidesPPT2Manufactureraccessdata.fda.gov
Driver, Wire, And Bone Drill, ManualDZJ2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufactureraccessdata.fda.gov
Knee Arthroplasty Implantation SystemOOG2Contract manufactureraccessdata.fda.gov
Orthopaedic Surgical Planning And Instrument GuidesPBF2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Contract manufactureraccessdata.fda.gov
Plate, Cranioplasty, Preformed, AlterableGWO2Manufactureraccessdata.fda.gov
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerHSN2Contract manufacturer, Manufactureraccessdata.fda.gov
Prosthesis, Ankle, Uncemented, Non-ConstrainedNTG3Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingNJL3Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Manufactureraccessdata.fda.gov
TemplateHWT1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 25, 2024K243174Cadence Ankle PSI SystemOYKSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
October 25, 2024K243173Salto Talaris Ankle PSI SystemOYKSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
August 30, 2024K241326Cadence Ankle PSI SystemOYKSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
August 30, 2024K241148Salto Talaris Ankle PSI SystemOYKSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
April 4, 2024K231834VSP PEEK Cranial ImplantGWOSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
March 30, 2022K214093VSP BolusIXISubstantially Equivalent3D Systemsaccessdata.fda.gov
November 10, 2021K211244VSP® Orthopedics SystemPBFSubstantially Equivalent3D Systemsaccessdata.fda.gov
April 26, 2021K210347VSP SystemDZJSubstantially Equivalent3D Systemsaccessdata.fda.gov
November 9, 2020K193432Vantage PSI SystemOYKSubstantially Equivalent3D Systemsaccessdata.fda.gov
February 26, 2020K192192VSP SystemDZJSubstantially Equivalent3D Systemsaccessdata.fda.gov
August 29, 2019K183489D2PLLZSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
August 21, 2019K190044VSP Orthopedics SystemPBFSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
January 9, 2017K161841D2PLLZSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
September 23, 2016K151285VSP Cranial SystemPPTSubstantially Equivalent3D Systems, Inc.accessdata.fda.gov
January 22, 2014K133907VSP SYSTEMDZJSubstantially EquivalentMedical Modeling, Inc.accessdata.fda.gov
December 12, 2012K120956VSP SYSTEMDZJSubstantially EquivalentMedical Modeling, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
May 17, 202290672Class IIOngoing3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-SterileScapula Marking Guide (anatomically Shaped) was incorrectly designed.accessdata.fda.gov

Compare with other makers

Updated October 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.