Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1724955

FEI Number

3003142829

Entity Name

MEDICAL MODELING - A 3D SYSTEMS COMPANY

City/State/Country

Littleton, CO, US

Establishment Address

5381 SOUTH ALKIRE CIRCLE, Littleton, CO 80127, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

3D Systems, Inc. (Owner Number: 9052197)

Owner / Operator Contact Address

5381 South Alkire Circle, Littleton, CO 80127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190044

PMA Number

N/A

All Registered Proprietary Names

VSP Bolus Klarity Prints Bolus CCSP Bolus CCSP Orthopedics VSP Orthopedics VSP Orthopaedics D2P 3D Systems Surgical Mask Salto Talaris Ankle PSI System Salto Talaris Ankle PSI System VSP Trauma VSP System VSP Orthognathics VSP Distraction VSP Reconstruction Jaw in a Day D2P VSP Cranial System Cadence Ankle PSI System 3D Printed Nasal Swab Cadence Ankle PSI System VSP Distraction VSP Trauma VSP Orthognathics VSP Reconstruction VSP System VSP Reconstruction VSP Orthognathics Jaw in a Day VSP Distraction VSP Trauma CardioView Anatomical Model AccuView Anatomical Model AccuDental Anatomical Model OsteoView Anatomical Model ClearView Anatomical Model ArthroView Anatomical Model VSP Orthopedics VSP Orthopaedics CCSP Orthopedics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXI	Block, Beam-Shaping, Radiation Therapy	Radiology	Class 2	892.5710	2022-06-29
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2023-02-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-25
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-16
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2025-04-23
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2025-04-23
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2024-09-03
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2024-11-06
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2024-11-06
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2023-02-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-02-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-08-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2017-08-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-01-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-05-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-05-16
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2018-05-16
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2018-05-16
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-10
PPT	Cranial Surgical Planning And Instrument Guides	Neurology	Class 2	882.4310	2016-10-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-05-21
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2025-01-10
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-01-10
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2024-09-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-05-21
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2022-11-17
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2024-11-06
OYK	Ankle Arthroplasty Implantation System	Orthopedic	Class 2	888.3110	2024-11-06
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2013-01-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-01-16
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2021-03-04
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-03-04
HWT	Template	Orthopedic	Class 1	888.4800	2002-07-19
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown	Class 3	N/A	2022-12-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-10
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-10
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2019-09-04

Official Correspondent

Archana Gopalan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

3D Systems, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3030977776	Ricoh 3D for Healthcare, LLC	Winston Salem, NC, US
1219183	HUESTIS MACHINE CORP.	Bristol, RI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1724955. Last updated year: 2026. Please use registration number 1724955 when referencing this establishment in official correspondence.