Vusion TS

GUDID 00822409033799

8 mm Parallel

Ortho Development Corporation

Vertebral body prosthesis

• Primary Device ID: 00822409033799
• NIH Device Record Key: d7f72e1c-aab3-4fd3-9d67-7b16692b49d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vusion TS
• Version Model Number: 551-5008A
• 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: false
• Expiration Date: true
• 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

Device Dimensions

• Height: 8 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409033799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062666

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-07-15

On-Brand Devices [Vusion TS]

• 00822409033881: 18 mm Parallel
• 00822409033874: 16 mm Parallel
• 00822409033867: 15 mm Parallel
• 00822409033850: 14 mm Parallel
• 00822409033843: 13 mm Parallel
• 00822409033836: 12 mm Parallel
• 00822409033829: 11 mm Parallel
• 00822409033812: 10 mm Parallel
• 00822409033805: 9 mm Parallel
• 00822409033799: 8 mm Parallel
• 00822409033782: 7mm Parallel
• 00822409033775: 15 mm 6 Degree Lordotic
• 00822409033768: 14 mm 6 Degree Lordotic
• 00822409033751: 13 mm 6 Degree Lordotic
• 00822409033744: 12 mm 6 Degree Lordotic
• 00822409033737: 11 mm 6 Degree Lordotic
• 00822409033720: 10 mm 6 Degree Lordotic
• 00822409033713: 9 mm 6 Degree Lordotic
• 00822409033706: 8 mm 6 Degree Lordotic
• 00822409033690: 7 mm 6 Degree Lordotic
• 00822409033683: 15 mm Parallel
• 00822409033676: 14 mm Parallel
• 00822409033669: 13 mm Parallel
• 00822409033652: 12 mm Parallel
• 00822409033645: 11 mm Parallel
• 00822409033638: 10 mm Parallel
• 00822409033621: 9 mm Parallel
• 00822409033614: 8 mm Parallel
• 00822409033607: 7mm Parallel
• 00822409033348: 18 mm 6 Degree Lordotic
• 00822409033331: 16 mm 6 Degree Lordotic
• 00822409033324: 15 mm 6 Degree Lordotic
• 00822409033317: 14 mm 6 Degree Lordotic
• 00822409033300: 13 mm 6 Degree Lordotic
• 00822409033294: 12 mm 6 Degree Lordotic
• 00822409033287: 11 mm 6 Degree Lordotic
• 00822409033270: 10 mm 6 Degree Lordotic
• 00822409033263: 9 mm 6 Degree Lordotic
• 00822409033256: 8 mm 6 Degree Lordotic
• 00822409033249: 7 mm 6 Degree Lordotic
• 00822409031207: 18 mm 6 Degree Lordotic
• 00822409031191: 16 mm 6 Degree Lordotic
• 00822409031184: 15 mm 6 Degree Lordotic
• 00822409031177: 14 mm 6 Degree Lordotic
• 00822409031160: 13 mm 6 Degree Lordotic
• 00822409031153: 12 mm 6 Degree Lordotic
• 00822409031146: 11 mm 6 Degree Lordotic
• 00822409031139: 10 mm 6 Degree Lordotic
• 00822409031122: 9 mm 6 Degree Lordotic
• 00822409031115: 8 mm 6 Degree Lordotic