Vusion OS
GUDID 00822409020874
9 mm x 20 mm x 11 mm 6 Degree Lordotic
Ortho Development Corporation
Polymeric spinal fusion cage, sterile| Primary Device ID | 00822409020874 |
| NIH Device Record Key | ce4724fd-a685-4c35-97e7-b38d1d9b6eb0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vusion OS |
| Version Model Number | 551-7211A |
| 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 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com |
Device Dimensions
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
| Angle | 6 degree |
| Height | 11 Millimeter |
| Width | 9 Millimeter |
| Length | 20 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00822409020874 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.