FDA.reportPublic FDA data

VSP System

Primary DI
00816847021241
Brand
VSP System
Company
3D SYSTEMS, INC.
Model
Resected Maxilla Model
Device description
A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120956000
K133907000
K192192000
K210347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120956000VSP SYSTEMMedical Modeling, Inc.2012-12-12DZJ
K133907000VSP SYSTEMMedical Modeling, Inc.2014-01-22DZJ
K192192000VSP System3D Systems2020-02-26DZJ
K210347000VSP System3D Systems2021-04-26DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847021241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847021241008168470212418168470212410816847021241

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8446431001Golden-CustomerService@3DSystems.Com

Regulatory Flags#

DUNS number
085049749
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816847021487VSP OrthopedicsPatient Femur Cutting Guide2019-09-11
00816847021494VSP OrthopedicsPatient Femur Marking Guide2019-09-11
00816847021500VSP OrthopedicsPatient Femur Drilling Guide2019-09-11
00816847021517VSP OrthopedicsPatient Femur Template2019-09-11
00816847021524VSP OrthopedicsPatient Tibia Cutting Guide2019-09-11
00816847021531VSP OrthopedicsPatient Tibia Marking Guide2019-09-11
00816847021548VSP OrthopedicsPatient Tibia Drilling Guide2019-09-11
00816847021555VSP OrthopedicsPatient Tibia Template2019-09-11
00816847021562VSP OrthopedicsPatient Pelvic Cutting Guide2019-09-11
00816847021579VSP OrthopedicsPatient Pelvic Marking Guide2019-09-11
00816847021586VSP OrthopedicsPatient Pelvic Drilling Guide2019-09-11
00816847021593VSP OrthopedicsPatient Pelvic Template2019-09-11
00816847021807VSP OrthopedicsAllograft Femur Cutting Guide2019-09-11
00816847021814VSP OrthopedicsAllograft Femur Marking Guide2019-09-11
00816847021821VSP OrthopedicsAllograft Femur Drilling Guide2019-09-11
00816847021838VSP OrthopedicsAllograft Femur Template2019-09-11
00816847021845VSP OrthopedicsAllograft Tibia Cutting Guide2019-09-11
00816847021852VSP OrthopedicsAllograft Tibia Marking Guide2019-09-11
00816847021869VSP OrthopedicsAllograft Tibia Drilling Guide2019-09-11
00816847021876VSP OrthopedicsAllograft Tibia Template2019-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVDZJ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20