FortiBridge® 10706-4012
GUDID 10814216022049
FortiBridge® Self-tap Fixed Screw 4.0x12mm
NANOVIS SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10814216022049 |
| NIH Device Record Key | c5b69a49-cb21-4233-a940-d55aabb6a599 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FortiBridge® |
| Version Model Number | 10706-4012 |
| Catalog Number | 10706-4012 |
| Company DUNS | 079898044 |
| Company Name | NANOVIS SPINE, LLC |
| Device Count | 2 |
| 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 | 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
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 12 Millimeter |
| Outer Diameter | 4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814216022059 [Unit of Use] |
| GS1 | 10814216022049 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162250
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-05-27 |
| Device Publish Date | 2016-12-02 |
On-Brand Devices [FortiBridge®]
| 00814216022134 | FortiBridgel Anterior Cervical Plate 4 Level x 81mm |
| 00814216022127 | FortiBridge Anterior Cervical Plate 4 Level x 77mm |
| 00814216022110 | FortiBridge Anterior Cervical Plate 4 level x 73mm |
| 00814216022103 | FortiBridge Anterior Cervical Plate 4 Level 69mm |
| 00814216021854 | FortiBridge® Variable Screw 4.5x16mm |
| 00814216021847 | FortiBridge® Variable Screw 4.5x14mm |
| 00814216021830 | FortiBridge® Variable Screw 4.5x12mm |
| 00814216021823 | FortiBridge® Variable Screw 4.5x10mm |
| 00814216021816 | FortiBridge® Fixed Screw 4.5x16mm |
| 00814216021809 | FortiBridge® Fixed Screw 4.5x14mm |
| 00814216021793 | FortiBridge® Fixed Screw 4.5x12mm |
| 00814216021786 | FortiBridge® Fixed Screw 4.5x10mm |
| 00814216021779 | FortiBridge Anterior Cervical Plate 3 Level x 69mm |
| 00814216021762 | FortiBridge Anterior Cervical Plate 3 Level x 66mm |
| 00814216021755 | FortiBridge Anterior Cervical Plate 3 Level x 63mm |
| 00814216021748 | FortiBridge Anterior Cervical Plate 3 Level x 66mm |
| 00814216021731 | FortiBridge Anterior Cervical Plate 3 Level x 57mm |
| 00814216021724 | FortiBridge Anterior Cervical Plate 3 Level x 54mm |
| 00814216021717 | FortiBridge Anterior Cervical Plate 3 Level x 51mm |
| 00814216021700 | FortiBridge Anterior Cervical Plate 3 Level x 48mm |
| 00814216021694 | FortiBridge Anterior Cervical Plate 2 Level x 46mm |
| 00814216021687 | FortiBridge Anterior Cervical Plate 2 Level x 44mm |
| 00814216021670 | FortiBridge Anterior Cervical Plate 2 Level x 42mm |
| 00814216021663 | FortiBridge Anterior Cervical Plate 2 Level x 40mm |
| 00814216021656 | FortiBridge Anterior Cervical Plate 2 Level x 38mm |
| 00814216021649 | FortiBridge Anterior Cervical Plate 2 Level x 36mm |
| 00814216021632 | FortiBridge Anterior Cervical Plate 2 Level x 34mm |
| 00814216021625 | FortiBridge Anterior Cervical Plate 2 Level x 32mm |
| 00814216021618 | FortiBridge Anterior Cervical Plate 2 Level x 30mm |
| 00814216021601 | FortiBridge Anterior Cervical Plate 2 Level x 28mm |
| 00814216021595 | FortiBridge Anterior Cervical Plate 1 Level x 24mm |
| 00814216021588 | FortiBridge Anterior Cervical Plate 1 Level x 22mm |
| 00814216021571 | FortiBridge Anterior Cervical Plate 1 Level x 20mm |
| 00814216021564 | FortiBridge Anterior Cervical Plate 1 Level 18mm |
| 00814216021557 | FortiBridge Anterior Cervical Plate 1 Level x 16mm |
| 00814216021540 | FortiBridge Anterior Cervical Plate 1 Level x 14mm |
| 00814216021533 | FortiBridge Anterior Cervical Plate 1 Level x 13mm |
| 00814216021526 | FortiBridge Anterior Cervical Plate 1 Level x 12mm |
| 00814216021519 | FortiBridge® Self-drill Variable Screw 4mm x 12mm |
| 00814216021427 | FortiBridge® 4.0 x 16 Self-Drill Screw, Fix |
| 00814216021410 | FortiBridge® 4.0 x 18 Self-Drill Screw, Fix |
| 00814216021403 | FortiBridge® 4.0 x 016 Self-Drill Screw, Fix |
| 00814216021397 | FortiBridge 4.0 x 14 Self-Drill Screw, Fixed |
| 00814216021380 | FortiBridge® 4.0 x 12 Self-Drill Screw, Fix |
| 00814216021373 | FortiBridge® Self-drill Fixed Screw 4.0 x 10 |
| 00814216021366 | FortiBridge® Self-Drill Variable Screw 4.0 x 20 |
| 00814216021359 | FortiBridge Self-drill Variable Screw 4.0 x 18 |
| 00814216021342 | FortiBridge® Self-drill Variable Screw 4.0 x 16 |
| 00814216021335 | FortiBridge® Self-drill Variable Screw 4.0 x 14 |
| 00814216021328 | FortiBridge® Self-drill Variable Screw 4.0 x 12 |
Trademark Results [FortiBridge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTIBRIDGE 85740408 4874716 Live/Registered |
Nanovis, LLC 2012-09-27 |
 FORTIBRIDGE 78764643 not registered Dead/Abandoned |
Fortinet Inc. 2005-12-01 |
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