Vusion PS

GUDID 00822409025879

12 mm Parallel

Ortho Development Corporation

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00822409025879
• NIH Device Record Key: 0fc414ac-5fd4-4fd2-b360-66ee0019fa3c
• Commercial Distribution Discontinuation: 2016-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vusion PS
• Version Model Number: 551-2012
• 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: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409025879 [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

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

Moist Heat or Steam Sterilization

[00822409025879]

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