Vantage PSI 351-80-11

GUDID 00816847022606

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

3D SYSTEMS, INC.

Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable

• Primary Device ID: 00816847022606
• NIH Device Record Key: a3a0d6cf-8b43-414a-836c-60df1da45f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vantage PSI
• Version Model Number: Fluoroscopic Insert
• Catalog Number: 351-80-11
• Company DUNS: 085049749
• Company Name: 3D SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com
• Phone: 8446431001
• Email: Golden-CustomerService@3DSystems.Com

Device Dimensions

• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816847022606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193432

FDA Product Code

• OYK: Ankle Arthroplasty Implantation System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

[00816847022606]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-30
• Device Publish Date: 2020-11-13

On-Brand Devices [Vantage PSI]

• 00816847022590: A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i
• 00816847022583: A physical guide that is composed of patient's bony anatomy and allows for precise location of p
• 00816847022606: Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cut
• 00816847022576: A physical guide that is composed of patient's bony anatomy and allows for precise location of p