Vusion PS

GUDID 00822409025824

7 mm Parallel

Ortho Development Corporation

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00822409025824
• NIH Device Record Key: d6f4fc68-0bae-44f7-a47c-b1b002e6572b
• Commercial Distribution Discontinuation: 2016-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vusion PS
• Version Model Number: 551-2007
• Company DUNS: 876542390
• Company Name: Ortho Development Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com
• Phone: +1(801)553-9991
• Email: customerservice@odev.com

Device Dimensions

• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter
• Height: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409025824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062666

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

[00822409025824]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-31

On-Brand Devices [Vusion PS]

• 00822409026609: 18 mm 12 Degree Lordotic
• 00822409026593: 16 mm 12 Degree Lordotic
• 00822409026586: 15 mm 12 Degree Lordotic
• 00822409026579: 14 mm 12 Degree Lordotic
• 00822409026562: 13 mm 12 Degree Lordotic
• 00822409026555: 12 mm 12 Degree Lordotic
• 00822409026548: 11 mm 12 Degree Lordotic
• 00822409026531: 10 mm 12 Degree Lordotic
• 00822409026524: 9 mm 12 Degree Lordotic
• 00822409026517: 8 mm 12 Degree Lordotic
• 00822409026500: 18 mm 6 Degree Lordotic
• 00822409026494: 16 mm 6 Degree Lordotic
• 00822409026487: 15 mm 6 Degree Lordotic
• 00822409026470: 14 mm 6 Degree Lordotic
• 00822409026463: 13 mm 6 Degree Lordotic
• 00822409026456: 12 mm 6 Degree Lordotic
• 00822409026449: 11 mm 6 Degree Lordotic
• 00822409026432: 10 mm 6 Degree Lordotic
• 00822409026425: 9 mm 6 Degree Lordotic
• 00822409026418: 8 mm 6 Degree Lordotic
• 00822409026401: 7 mm 6 Degree Lordotic
• 00822409026395: 18 mm 6 Degree Lordotic
• 00822409026388: 16 mm 6 Degree Lordotic
• 00822409026371: 15 mm 6 Degree Lordotic
• 00822409026364: 14 mm 6 Degree Lordotic
• 00822409026357: 13 mm 6 Degree Lordotic
• 00822409026340: 12 mm 6 Degree Lordotic
• 00822409026333: 11 mm 6 Degree Lordotic
• 00822409026326: 10 mm 6 Degree Lordotic
• 00822409026319: 9 mm 6 Degree Lordotic
• 00822409026302: 8 mm 6 Degree Lordotic
• 00822409026296: 7 mm 6 Degree Lordotic
• 00822409026289: 18 mm Parallel
• 00822409026272: 16 mm Parallel
• 00822409026265: 15 mm Parallel
• 00822409026258: 14 mm Parallel
• 00822409026241: 13 mm Parallel
• 00822409026234: 12 mm Parallel
• 00822409026227: 11 mm Parallel
• 00822409026210: 10 mm Parallel
• 00822409026203: 9 mm Parallel
• 00822409026197: 8 mm Parallel
• 00822409026180: 7 mm Parallel
• 00822409026173: 6 mm Parallel
• 00822409026050: 14 mm 12 Degree Lordotic
• 00822409026043: 13 mm 12 Degree Lordotic
• 00822409026036: 12 mm 12 Degree Lordotic
• 00822409026029: 11 mm 12 Degree Lordotic
• 00822409026012: 10 mm 12 Degree Lordotic
• 00822409026005: 9 mm 12 Degree Lordotic