MedtechSourcebook

MEDICAL MODELING - A 3D SYSTEMS COMPANY

Contract manufacturer · Littleton, CO

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1724955 (openFDA record; or search FDA's registration database)
FEI number
3003142829
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
3D Systems, Inc. (FDA owner/operator no. 9052197)
Registered address
5381 SOUTH ALKIRE CIRCLE, Littleton, CO 80127
Contract listings
12 device listings, 14 product codes, first listed Oct 31, 2013
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerClass IIOrthopedicContract manufacturingApr 23, 2025
HTNWasher, Bolt NutClass IIOrthopedicContract manufacturingAug 17, 2017
HWCScrew, Fixation, BoneClass IIOrthopedicContract manufacturingAug 17, 2017
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerClass IIOrthopedicContract manufacturingOct 31, 2013
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMay 21, 2020
MAXIntervertebral Fusion Device With Bone Graft, LumbarClass IIOrthopedicContract manufacturingMay 16, 2018
MNIOrthosis, Spinal Pedicle FixationClass IIOrthopedicContract manufacturingJan 13, 2017
NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingClass IIIOrthopedicContract manufacturingOct 31, 2016
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedClass IIIOrthopedicContract manufacturingDec 21, 2022
ODPIntervertebral Fusion Device With Bone Graft, CervicalClass IIOrthopedicContract manufacturingMay 16, 2018
OOGKnee Arthroplasty Implantation SystemClass IIOrthopedicContract manufacturingOct 31, 2013
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarClass IIOrthopedicContract manufacturingMay 16, 2018
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalClass IIOrthopedicContract manufacturingMay 16, 2018
OYKAnkle Arthroplasty Implantation SystemClass IIOrthopedicContract manufacturingApr 23, 2025