Vusion CS Plus

GUDID 00822409033546

16 mm x 10 mm x Parallel

Ortho Development Corporation

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00822409033546
• NIH Device Record Key: 66ed4135-aa57-4038-8b04-2a42c711af8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vusion CS Plus
• Version Model Number: 159-1610-00A
• 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
• 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: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter
• Width: 16 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409033546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122588

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-15

On-Brand Devices [Vusion CS Plus]

• 00822409035076: 14 mm x 6 mm x Parallel
• 00822409035069: 14 mm x 5 mm x Parallel
• 00822409035052: 12 mm x 12 mm x Parallel
• 00822409035045: 12 mm x 11 mm x Parallel
• 00822409035038: 12 mm x 10 mm x Parallel
• 00822409035021: 12 mm x 9 mm x Parallel
• 00822409035014: 12 mm x 8 mm x Parallel
• 00822409035007: 12 mm x 7 mm x Parallel
• 00822409034994: 12 mm x 6 mm x Parallel
• 00822409034987: 12 mm x 5 mm x Parallel
• 00822409033591: 16 mm x 12 mm x 7 Degree Lordotic
• 00822409033584: 16 mm x 12 mm x Parallel
• 00822409033577: 16 mm x 11 mm x 7 Degree Lordotic
• 00822409033560: 16 mm x 11 mm x Parallel
• 00822409033553: 16 mm x 10 mm x 7 Degree Lordotic
• 00822409033546: 16 mm x 10 mm x Parallel
• 00822409033539: 16 mm x 9 mm x 7 Degree Lordotic
• 00822409033522: 16 mm x 9 mm x Parallel
• 00822409033515: 16 mm x 8 mm x 7 Degree Lordotic
• 00822409033508: 16 mm x 8 mm x Parallel
• 00822409033492: 16 mm x 7 mm x 7 Degree Lordotic
• 00822409033485: 16 mm x 7 mm x Parallel
• 00822409033478: 16 mm x 6 mm x 7 Degree Lordotic
• 00822409033461: 16 mm x 6 mm x Parallel
• 00822409033454: 16 mm x 5 mm x 7 Degree Lordotic
• 00822409033447: 16 mm x 5 mm x Parallel
• 00822409033430: 14 mm x 12 mm x Parallel
• 00822409033423: 14 mm x 11 mm x Parallel
• 00822409033416: 14 mm x 10 mm x Parallel
• 00822409033409: 14 mm x 9 mm x Parallel
• 00822409033393: 14 mm x 8 mm x Parallel
• 00822409033386: 14 mm x 7 mm x Parallel
• 00822409033379: 12 mm x 7 mm x 7 Degree Lordotic
• 00822409033362: 12 mm x 6 mm x 7 Degree Lordotic
• 00822409033355: 12 mm x 5 mm x 7 Degree Lordotic
• 00822409033232: 14 mm x 12 mm x 7 Degree Lordotic
• 00822409033225: 14 mm x 11 mm x 7 Degree Lordotic
• 00822409033218: 14 mm x 10 mm x 7 Degree Lordotic
• 00822409033201: 14 mm x 9 mm x 7 Degree Lordotic
• 00822409033195: 14 mm x 8 mm x 7 Degree Lordotic
• 00822409033188: 14 mm x 7 mm x 7 Degree Lordotic
• 00822409033171: 14 mm x 6 mm x 7 Degree Lordotic
• 00822409033164: 14 mm x 5 mm x 7 Degree Lordotic
• 00822409033157: 12 mm x 12 mm x 7 Degree Lordotic
• 00822409033140: 12 mm x 11 mm x 7 Degree Lordotic
• 00822409033133: 12 mm x 10 mm x 7 Degree Lordotic
• 00822409033126: 12 mm x 9 mm x 7 Degree Lordotic
• 00822409033119: 12 mm x 8 mm x 7 Degree Lordotic
• 00822409025626: 16 mm x 12 mm x 7 Degree Lordotic
• 00822409025619: 16 mm x 12 mm x Parallel