VSP System, VSP Cranial

Basic Information

• Brand Name: VSP System, VSP Cranial
• Primary DI: 00816847021272
• Version / Model: Bone Graft Template
• Company Name: 3D SYSTEMS, INC.
• Labeler DUNS: 085049749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: fd7bf0b2-fc6f-4ba6-9c59-879ca3d468de

Device Description

A three dimensional physical model depicting patient specific anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf implants.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	872.4120	2
PPT	Cranial Surgical Planning And Instrument Guides	Neurology	882.4310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58804	Surgical implant template, single-use	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816847021272	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K120956	000
K133907	000
K151285	000
K192192	000
K210347	000