NEWBRIDGE
GUDID 18257200031931
3.2MM X 8 MM RESCUE LATERAL MASS BONE SCREW, NEWBRIDGE LFS
ORTHOFIX INC.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 18257200031931 |
| NIH Device Record Key | c8b0eb1d-3430-4a2a-b9da-2713e72a0865 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEWBRIDGE |
| Version Model Number | 40-3208 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200031931 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043338
FDA Product Code
| NQW | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
[18257200031931]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
On-Brand Devices [NEWBRIDGE]
| 18257200081110 | NEWBRIDGE LAMINOPLASTY FIXATION SYSTEM (40-9001) |
| 18257200032037 | 12MM TRIAL SPACER, NEWBRIDGE LFS |
| 18257200032020 | 10MM TRIAL SPACER, NEWBRIDGE LFS |
| 18257200032013 | 8MM TRIAL SPACER, NEWBRIDGE LFS |
| 18257200032006 | 6MM TRIAL SPACER, NEWBRIDGE LFS |
| 18257200031993 | 4MM TRIAL SPACER, NEWBRIDGE LFS |
| 18257200031931 | 3.2MM X 8 MM RESCUE LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031924 | 3.2MM X 7 MM RESCUE LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031917 | 3.2MM X 6 MM RESCUE LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031900 | 3.2MM X 5 MM RESCUE LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031894 | 2.7MM X 8MM PRIMARY LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031887 | 2.7MM X 7MM PRIMARY LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031870 | 2.7MM X 6MM PRIMARY LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031863 | 2.7MM X 5MM PRIMARY LATERAL MASS BONE SCREW, NEWBRIDGE LFS |
| 18257200031856 | 2.5MM X 6.0MM RESCUE LAMINA AND ALLOGRAFT BONE SCEW, NEWBRIDGE LFS |
| 18257200031849 | 2.0MM X 5.0MM PRIMARY LAMINA AND ALLOGRAFT BONE SCEW, NEWBRIDGE LFS |
| 18257200031825 | BONE GRAFT PUNCH |
| 18257200031818 | LAMINA ELEVATOR, NEWBRIDGE LFS |
| 18257200031801 | BENDING IRON, NEWBRIDGE LFS |
| 18257200031795 | 2.7MM DRILL BIT - 8MM LENGTH, NEWBRIDGE LFS |
| 18257200031788 | 2.7MM DRILL BIT - 5MM LENGTH, NEWBRIDGE LFS |
| 18257200031771 | 2.0MM DRILL BIT - 5MM LENGTH, NEWBRIDGE LFS |
| 18257200031764 | 2.0MM DRILL BIT - 3MM LENGTH, NEWBRIDGE LFS |
| 18257200031757 | LATERAL MASS SCREWDRIVER, NEWBRIDGE LFS |
| 18257200031740 | 2.0MM LAMINA AND ALLOGRAFT SCREWDRIVER, NEWBRIDGE LFS |
| 18257200031733 | LEFT HANDED PLATE HOLDER, NEWBRIDGE LFS |
| 18257200031726 | RIGHT HANDED PLATE HOLDER, NEWBRIDGE LFS |
| 18257200031702 | LARGE PLATE, NEWBRIDGE LFS |
| 18257200031696 | MEDIUM PLATE, NEWBRIDGE LFS |
| 18257200031689 | Small Plate |
Trademark Results [NEWBRIDGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEWBRIDGE 88208001 5811590 Live/Registered |
Capelouto, Nina 2018-11-28 |
NEWBRIDGE 88208001 5811590 Live/Registered |
Anderson, Connie 2018-11-28 |
 NEWBRIDGE 88055323 not registered Live/Pending |
East Madison/Monona Coalition of the Aging, Inc. 2018-07-27 |
 NEWBRIDGE 86551002 4925289 Live/Registered |
Avery, Mark Langer 2015-03-03 |
 NEWBRIDGE 86412735 5435775 Live/Registered |
MADRIDFILER HOLDINGS LTD 2014-10-02 |
 NEWBRIDGE 86308082 4671527 Live/Registered |
F.N.B. CORPORATION 2014-06-12 |
 NEWBRIDGE 86199892 not registered Dead/Abandoned |
NewBridge Behavioral Health, LLC 2014-02-21 |
 NEWBRIDGE 79096211 4910613 Live/Registered |
The Newbridge Cutlery Company Limited Company t/a Newbridge Silverware 2010-10-14 |
 NEWBRIDGE 78936901 not registered Dead/Abandoned |
TARRANT CAPITAL IP, LLC. 2006-07-25 |
 NEWBRIDGE 78132365 2793042 Dead/Cancelled |
MI WINDOWS AND DOORS, INC. 2002-05-31 |
 NEWBRIDGE 77951898 3971538 Dead/Cancelled |
Cleveland Center for Arts and Technology 2010-03-05 |
 NEWBRIDGE 77951825 3967419 Dead/Cancelled |
Cleveland Center for Arts and Technology 2010-03-05 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.