FDA.reportPublic FDA data

VSP System, VSP Cranial

Primary DI
00816847021333
Brand
VSP System, VSP Cranial
Company
3D SYSTEMS, INC.
Model
Metal Slot (25mm)
Device description
Reusable accessory Cutting insert
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
LLZSystem, Image Processing, Radiological
PPTCranial Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
LLZSystem, Image Processing, RadiologicalRadiology2
PPTCranial Surgical Planning And Instrument GuidesNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816847021333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816847021333008168470213338168470213330816847021333

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guideA non-sterile surgical instrument intended to be attached to a portion of bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure to outline the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter

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
00816847022859VSP PEEKHost Skull Model2025-11-10
00816847022736Salto Talaris Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022750Salto Talaris Flat Cut Total Ankle SystemAnatomical Model2025-01-10
00816847022767Cadence Flat Cut Total Ankle SystemTalus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle SystemTibia Cutting Guide2025-01-10
00816847022781Cadence Flat Cut Total Ankle SystemAnatomical model2025-01-10
00816847022637Cadence Chamfer Cut Total Ankle SystemAnatomical model2024-09-12
00816847022651Salto Talaris Chamfer Cut Total Ankle SystemAnatomical Model2024-09-12
00816847022675VSP PEEKCranial Implant2024-09-12
00816847022699Salto Talaris Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle SystemTalus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle SystemTibia Cutting Guide2024-09-12
00816847022798Vantage 3D PSITibia Cutting Guide2024-08-05
00816847022804Vantage 3D PSITalus Cutting Guide2024-08-05
00816847022811Vantage 3D PSIAnatomical Model2024-08-05
00816847022828Vantage 3D+ PSITibia Cutting Guide2024-08-05
00816847022835Vantage 3D+ PSITalus Cutting Guide2024-08-05
00816847022842Vantage 3D+ PSIAnatomical Model2024-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854393006084VelocityVARIAN MEDICAL SYSTEMS, INC.LLZ2026-07-16
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26