PressON
GUDID B6785208890
LevelUP Rivet
NEXUS SPINE, L.L.C.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | B6785208890 |
| NIH Device Record Key | 72618d88-0765-4d5b-8dd8-8fe44ebb318d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PressON |
| Version Model Number | 520889 |
| Company DUNS | 028137605 |
| Company Name | NEXUS SPINE, L.L.C. |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B6785208890 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233234
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
[B6785208890]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-09 |
| Device Publish Date | 2024-05-01 |
On-Brand Devices [PressON]
| B6785202170 | MIS Pedicle Screw 5.5mm x 35mm, Cannulated |
| B6785202160 | MIS Pedicle Screw 5.5mm x 30mm, Cannulated |
| B6785202150 | MIS Pedicle Screw 5.5mm x 25mm, Cannulated |
| B6785201470 | End Coupler |
| B6785208930 | LevelUP Rivet |
| B6785208920 | LevelUP Coupler, Right |
| B6785208910 | LevelUP Coupler, Left |
| B6785208900 | LevelUP Coupler, Straight |
| B6785208890 | LevelUP Rivet |
| B6785208870 | LevelUP Coupler, Right |
| B6785208860 | LevelUP Coupler, Left |
| B6785208850 | LevelUP Coupler, Straight |
| B6785203050 | Fixed Length Coupler 77.5mm |
| B6785203030 | Fixed Length Coupler 72.5mm |
| B6785203010 | Fixed Length Coupler 67.5mm |
| B6785202990 | Fixed Length Coupler 62.5mm |
| B6785201610 | End LevelUP Coupler, Right |
| B6785201600 | End LevelUP Coupler, Left |
| B6785201590 | End LevelUP Coupler, Straight |
Trademark Results [PressON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRESSON 88200143 not registered Live/Pending |
Persyst Development Corporation 2018-11-19 |
 PRESSON 86180499 4846697 Live/Registered |
LiveLoud Charities 2014-01-30 |
 PRESSON 85680824 4653287 Live/Registered |
NEXUS SPINE, L.L.C. 2012-07-18 |
 PRESSON 85207985 not registered Dead/Abandoned |
NewspaperDirect Inc. 2010-12-30 |
 PRESSON 85207964 not registered Dead/Abandoned |
NewspaperDirect Inc. 2010-12-30 |
 PRESSON 79186977 not registered Dead/Abandoned |
Presson Oy 2015-11-17 |
 PRESSON 78337304 2984129 Dead/Cancelled |
ENERFLEX LTD. 2003-12-05 |
 PRESSON 77203163 not registered Dead/Abandoned |
Persyst Development Corporation, Inc. 2007-06-11 |
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