Medical Modeling - a 3D Systems Company

Littleton, CO, US

MEDICAL MODELING - A 3D SYSTEMS COMPANY appears in FDA device records in Littleton, CO. FDA records list 2 510(k) clearances between 2012-12-12 and 2014-01-22, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Medical Modeling - a 3D Systems Company carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Medical Modeling, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Medical Modeling - a 3D Systems Company between 2012 and 2014. The busiest year on record is 2012, with 1. The most recent is 2014, with 1.

Clearances by year, as a table

510(k) clearance decisions for Medical Modeling - a 3D Systems Company, by decision year
Year	Clearances
2012	1
2014	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K133907	VSP SYSTEM	DZJ	Substantially Equivalent	2014-01-22
K120956	VSP SYSTEM	DZJ	Substantially Equivalent	2012-12-12

Registered establishments

FDA registered establishments for Medical Modeling - a 3D Systems Company, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1724955	3003142829	MEDICAL MODELING - A 3D SYSTEMS COMPANY	5381 SOUTH ALKIRE CIRCLE, Littleton, CO 80127 US	2026	DZJ GWO HSN HTN HWC HWT IXI JWH KXG LLZ and 13 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1510-2022	3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile	Scapula Marking Guide (anatomically Shaped) was incorrectly designed.	Class II	2022-05-17	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain