Vantage PSI

Basic Information

• Brand Name: Vantage PSI
• Primary DI: 00816847022606
• Version / Model: Fluoroscopic Insert
• Catalog Number: 351-80-11
• Company Name: 3D SYSTEMS, INC.
• Labeler DUNS: 085049749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 2
• Public Version Date: 2023-08-30
• Public Version Status: Update
• Public Device Record Key: a3a0d6cf-8b43-414a-836c-60df1da45f93

Device Description

Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides.

Device Characteristics

• Single Use: No
• 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
OYK	Ankle Arthroplasty Implantation System	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61917	Osteotomy guide, reusable	A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816847022606	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193432	000

Device Sizes

Type	Value	Unit	Text
Length	25	Millimeter