Ibis
GUDID 00822409019489
Diameter 5.5 mm x 75 mm Straight Bulleted Rod Ti
Ortho Development Corporation
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 00822409019489 |
| NIH Device Record Key | febdbd69-ea8f-480d-8000-56e68a1f8618 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ibis |
| Version Model Number | 158-1075-03A |
| 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 | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 75 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00822409019489 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142146
FDA Product Code
| NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
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 [Ibis]
| 00822409029907 | Diameter 8.5 mm x 60 mm Cannulated Monoaxial Screw |
| 00822409029884 | Diameter 8.5 mm x 60 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029877 | Diameter 8.5 mm x 60 mm Cannulated Polyaxial Screw |
| 00822409029846 | Diameter 8.5 mm x 55 mm Cannulated Monoaxial Screw |
| 00822409029822 | Diameter 8.5 mm x 55 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029815 | Diameter 8.5 mm x 55 mm Cannulated Polyaxial Screw |
| 00822409029785 | Diameter 8.5 mm x 50 mm Cannulated Monoaxial Screw |
| 00822409029761 | Diameter 8.5 mm x 50 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029754 | Diameter 8.5 mm x 50 mm Cannulated Polyaxial Screw |
| 00822409029723 | Diameter 8.5 mm x 45 mm Cannulated Monoaxial Screw |
| 00822409029709 | Diameter 8.5 mm x 45 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029693 | Diameter 8.5 mm x 45 mm Cannulated Polyaxial Screw |
| 00822409029662 | Diameter 8.5 mm x 40 mm Cannulated Monoaxial Screw |
| 00822409029648 | Diameter 8.5 mm x 40 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029631 | Diameter 8.5 mm x 40 mm Cannulated Polyaxial Screw |
| 00822409029600 | Diameter 8.5 mm x 35 mm Cannulated Monoaxial Screw |
| 00822409029587 | Diameter 8.5 mm x 35 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029570 | Diameter 8.5 mm x 35 mm Cannulated Polyaxial Screw |
| 00822409029549 | Diameter 8.5 mm x 30 mm Cannulated Monoaxial Screw |
| 00822409029525 | Diameter 8.5 mm x 30 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029518 | Diameter 8.5 mm x 30 mm Cannulated Polyaxial Screw |
| 00822409029457 | Diameter 7.5 mm x 60 mm Cannulated Monoaxial Screw |
| 00822409029433 | Diameter 7.5 mm x 60 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029426 | Diameter 7.5 mm x 60 mm Cannulated Polyaxial Screw |
| 00822409029396 | Diameter 7.5 mm x 55 mm Cannulated Monoaxial Screw |
| 00822409029372 | Diameter 7.5 mm x 55 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029365 | Diameter 7.5 mm x 55 mm Cannulated Polyaxial Screw |
| 00822409029334 | Diameter 7.5 mm x 50 mm Cannulated Monoaxial Screw |
| 00822409029310 | Diameter 7.5 mm x 50 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029303 | Diameter 7.5 mm x 50 mm Cannulated Polyaxial Screw |
| 00822409029273 | Diameter 7.5 mm x 45 mm Cannulated Monoaxial Screw |
| 00822409029259 | Diameter 7.5 mm x 45 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029242 | Diameter 7.5 mm x 45 mm Cannulated Polyaxial Screw |
| 00822409029211 | Diameter 7.5 mm x 40 mm Cannulated Monoaxial Screw |
| 00822409029198 | Diameter 7.5 mm x 40 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029181 | Diameter 7.5 mm x 40 mm Cannulated Polyaxial Screw |
| 00822409029150 | Diameter 7.5 mm x 35 mm Cannulated Monoaxial Screw |
| 00822409029136 | Diameter 7.5 mm x 35 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029129 | Diameter 7.5 mm x 35 mm Cannulated Polyaxial Screw |
| 00822409029099 | Diameter 7.5 mm x 30 mm Cannulated Monoaxial Screw |
| 00822409029075 | Diameter 7.5 mm x 30 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409029068 | Diameter 7.5 mm x 30 mm Cannulated Polyaxial Screw |
| 00822409029006 | Diameter 6.5 mm x 60 mm Cannulated Monoaxial Screw |
| 00822409028986 | Diameter 6.5 mm x 60 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409028979 | Diameter 6.5 mm x 60 mm Cannulated Polyaxial Screw |
| 00822409028948 | Diameter 6.5 mm x 55 mm Cannulated Monoaxial Screw |
| 00822409028924 | Diameter 6.5 mm x 55 mm, 90 mm Cannulated Screw Extended Tab |
| 00822409028917 | Diameter 6.5 mm x 55 mm Cannulated Polyaxial Screw |
| 00822409028887 | Diameter 6.5 mm x 50 mm Cannulated Monoaxial Screw |
| 00822409028863 | Diameter 6.5 mm x 50 mm, 90 mm Cannulated Screw Extended Tab |
Trademark Results [Ibis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IBIS 97937181 not registered Live/Pending |
Iowa Bankers Association 2023-05-15 |
 IBIS 90595898 not registered Live/Pending |
National Oilwell Varco, L.P. 2021-03-23 |
 IBIS 88890981 not registered Live/Pending |
Educational Testing Service 2020-04-28 |
 IBIS 88675680 not registered Live/Pending |
Gottlieb, Aaron 2019-10-31 |
 IBIS 88497827 not registered Live/Pending |
Charles, Duclas M 2019-07-02 |
 IBIS 88397762 5880163 Live/Registered |
IBIS America, Inc. 2019-04-23 |
 IBIS 88051551 not registered Live/Pending |
NightOwl Discovery, Inc. 2018-07-25 |
 IBIS 88028513 5803567 Live/Registered |
Ultra Electronics Forensic Technology Inc. 2018-07-06 |
 IBIS 87435786 not registered Live/Pending |
Alina Ivette Torrens 2017-05-03 |
 IBIS 87095310 not registered Dead/Abandoned |
Cameron, Nathan R 2016-07-07 |
 IBIS 86700994 4859905 Live/Registered |
Ibis International, Inc. 2015-07-22 |
 IBIS 86558685 4944233 Live/Registered |
ACCOR 2015-03-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.