Vusion OS

GUDID 00822409020546

11 mm x 25 mm x 9 mm Parallel

Ortho Development Corporation

Polymeric spinal fusion cage, sterile

Primary Device ID	00822409020546
NIH Device Record Key	6ec379e0-85a6-4ca4-b381-a11e4b16ffb6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vusion OS
Version Model Number	551-6509A
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

Length	25 Millimeter
Length	25 Millimeter
Length	25 Millimeter
Length	25 Millimeter
Length	25 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter
Height	9 Millimeter
Width	11 Millimeter
Length	25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822409020546 [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

Trademark Results [Vusion OS]

Mark Image Registration \| Serial	Company Trademark Application Date
VUSION OS 79367572 not registered Live/Pending	SES-IMAGOTAG 2022-10-07