Vusion OS

GUDID 00822409020287

9 mm x 25 mm x 10 mm Parallel

Ortho Development Corporation

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00822409020287
• NIH Device Record Key: ce014e19-cde5-495e-ad1e-074405f4229f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vusion OS
• Version Model Number: 551-6210A
• 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
• Height: 10 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter
• Length: 25 Millimeter
• Width: 9 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409020287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111965

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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 OS]

• 00822409027699: 11 mm x 25 mm x 16 mm 6 Degree Lordotic
• 00822409027682: 11 mm x 25 mm x 15 mm 6 Degree Lordotic
• 00822409027675: 11 mm x 25 mm x 14 mm 6 Degree Lordotic
• 00822409027668: 11 mm x 25 mm x 13 mm 6 Degree Lordotic
• 00822409027651: 11 mm x 25 mm x 12 mm 6 Degree Lordotic
• 00822409027644: 11 mm x 25 mm x 11 mm 6 Degree Lordotic
• 00822409027637: 11 mm x 25 mm x 10 mm 6 Degree Lordotic
• 00822409027620: 11 mm x 25 mm x 9 mm 6 Degree Lordotic
• 00822409027613: 11 mm x 20 mm x 16 mm 6 Degree Lordotic
• 00822409027606: 11 mm x 20 mm x 15 mm 6 Degree Lordotic
• 00822409027590: 11 mm x 20 mm x 14 mm 6 Degree Lordotic
• 00822409027583: 11 mm x 20 mm x 13 mm 6 Degree Lordotic
• 00822409027576: 11 mm x 20 mm x 12 mm 6 Degree Lordotic
• 00822409027569: 11 mm x 20 mm x 11 mm 6 Degree Lordotic
• 00822409027552: 11 mm x 20 mm x 10 mm 6 Degree Lordotic
• 00822409027545: 11 mm x 20 mm x 9 mm 6 Degree Lordotic
• 00822409027538: 9 mm x 25 mm x 16 mm 6 Degree Lordotic
• 00822409027521: 9 mm x 25 mm x 15 mm 6 Degree Lordotic
• 00822409027514: 9 mm x 25 mm x 14 mm 6 Degree Lordotic
• 00822409027507: 9 mm x 25 mm x 13 mm 6 Degree Lordotic
• 00822409027491: 9 mm x 25 mm x 12 mm 6 Degree Lordotic
• 00822409027484: 9 mm x 25 mm x 11 mm 6 Degree Lordotic
• 00822409027477: 9 mm x 25 mm x 10 mm 6 Degree Lordotic
• 00822409027460: 9 mm x 25 mm x 9 mm 6 Degree Lordotic
• 00822409027453: 9 mm x 25 mm x 12 mm 3 Degree Lordotic
• 00822409027446: 9 mm x 25 mm x 11 mm 3 Degree Lordotic
• 00822409027439: 9 mm x 25 mm x 10 mm 3 Degree Lordotic
• 00822409027422: 9 mm x 25 mm x 9 mm 3 Degree Lordotic
• 00822409027415: 9 mm x 25 mm x 8 mm 3 Degree Lordotic
• 00822409027408: 9 mm x 25 mm x 7 mm 3 Degree Lordotic
• 00822409027392: 9 mm x 20 mm x 16 mm 6 Degree Lordotic
• 00822409027385: 9 mm x 20 mm x 15 mm 6 Degree Lordotic
• 00822409027378: 9 mm x 20 mm x 14 mm 6 Degree Lordotic
• 00822409027361: 9 mm x 20 mm x 13 mm 6 Degree Lordotic
• 00822409027354: 9 mm x 20 mm x 12 mm 6 Degree Lordotic
• 00822409027347: 9 mm x 20 mm x 11 mm 6 Degree Lordotic
• 00822409027330: 9 mm x 20 mm x 10 mm 6 Degree Lordotic
• 00822409027323: 9 mm x 20 mm x 9 mm 6 Degree Lordotic
• 00822409027316: 9 mm x 20 mm x 12 mm 3 Degree Lordotic
• 00822409027309: 9 mm x 20 mm x 11 mm 3 Degree Lordotic
• 00822409027293: 9 mm x 20 mm x 10 mm 3 Degree Lordotic
• 00822409027286: 9 mm x 20 mm x 9 mm 3 Degree Lordotic
• 00822409027279: 9 mm x 20 mm x 8 mm 3 Degree Lordotic
• 00822409027262: 9 mm x 20 mm x 7 mm 3 Degree Lordotic
• 00822409027255: 11 mm x 35 mm x 16 mm Parallel
• 00822409027248: 11 mm x 35 mm x 15 mm Parallel
• 00822409027231: 11 mm x 35 mm x 14 mm Parallel
• 00822409027224: 11 mm x 35 mm x 13 mm Parallel
• 00822409027217: 11 mm x 35 mm x 12 mm Parallel
• 00822409027200: 11 mm x 35 mm x 11 mm Parallel