PressON™
GUDID B678820332BH0
PressON Curved Lenke Probe - Ball Handle (1.8")
NEXUS SPINE, L.L.C.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | B678820332BH0 |
| NIH Device Record Key | 19a171d4-dfda-4e0c-886a-2956cc731c84 |
| Commercial Distribution Discontinuation | 2023-06-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | PressON™ |
| Version Model Number | 820332BH |
| 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B678820332BH0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133287
FDA Product Code
| MNI | Orthosis, Spinal Pedicle Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
[B678820332BH0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-09 |
| Device Publish Date | 2022-02-28 |
On-Brand Devices [PressON™]
| B6788203200 | MIS Nitinol Guidewire XL |
| B6788202080 | MIS Nitinol Guidewire |
| B6788200640 | Guide Wire - 1.4mm |
| B6785208330 | MIS Pedicle Screw 8.5 x 100mm, Cannulated |
| B6785208320 | MIS Pedicle Screw 8.5 x 95mm, Cannulated |
| B6785208310 | MIS Pedicle Screw 8.5 x 90mm, Cannulated |
| B6785208300 | MIS Pedicle Screw 8.5 x 85mm, Cannulated |
| B6785208290 | MIS Pedicle Screw 7.5 x 100mm, Cannulated |
| B6785208280 | MIS Pedicle Screw 7.5 x 95mm, Cannulated |
| B6785208270 | MIS Pedicle Screw 7.5 x 90mm, Cannulated |
| B6785208260 | MIS Pedicle Screw 7.5 x 85mm, Cannulated |
| B6785208250 | MIS Pedicle Screw 7.5 x 80mm, Cannulated |
| B6785208240 | MIS Pedicle Screw 7.5 x 75mm, Cannulated |
| B6785208230 | MIS Pedicle Screw 7.5 x 70mm, Cannulated |
| B6785208220 | MIS Pedicle Screw 7.5 x 65mm, Cannulated |
| B6785208210 | MIS Cortical Screw 6.0 x 50mm, Cannulated, Self-starting |
| B6785208200 | MIS Cortical Screw 6.0 x 45mm, Cannulated, Self-starting |
| B6785208190 | MIS Cortical Screw 6.0 x 40mm, Cannulated, Self-starting |
| B6785208180 | MIS Cortical Screw 6.0 x 35mm, Cannulated, Self-starting |
| B6785208170 | MIS Cortical Screw 6.0 x 30mm, Cannulated, Self-starting |
| B6785208160 | MIS Cortical Screw 6.5 x 50mm, Self-starting |
| B6785208150 | MIS Cortical Screw 6.5 x 45mm, Self-starting |
| B6785208140 | MIS Cortical Screw 6.5 x 40mm, Self-starting |
| B6785208130 | MIS Cortical Screw 6.5 x 35mm, Self-starting |
| B6785208120 | MIS Cortical Screw 6.5 x 30mm, Self-starting |
| B6785208110 | MIS Cortical Screw 5.5 x 50mm, Self-starting |
| B6785208100 | MIS Cortical Screw 5.5 x 45mm, Self-starting |
| B6785208090 | MIS Cortical Screw 5.5 x 40mm, Self-starting |
| B6785208080 | MIS Cortical Screw 5.5 x 35mm, Self-starting |
| B6785208070 | MIS Cortical Screw 5.5 x 30mm, Self-starting |
| B6785208060 | MIS Cortical Screw 6.5 x 50mm, Cannulated |
| B6785208050 | MIS Cortical Screw 6.5 x 45mm, Cannulated |
| B6785208040 | MIS Cortical Screw 6.5 x 40mm, Cannulated |
| B6785208030 | MIS Cortical Screw 6.5 x 35mm, Cannulated |
| B6785208020 | MIS Cortical Screw 6.5 x 30mm, Cannulated |
| B6785208010 | MIS Cortical Screw 5.5 x 50mm, Cannulated |
| B6785208000 | MIS Cortical Screw 5.5 x 45mm, Cannulated |
| B6785207990 | MIS Cortical Screw 5.5 x 40mm, Cannulated |
| B6785207980 | MIS Cortical Screw 5.5 x 35mm, Cannulated |
| B6785207970 | MIS Cortical Screw 5.5 x 30mm, Cannulated |
| B6785207840 | MIS Cortical Screw 5.0 x 50mm, Cannulated, Self-starting |
| B6785207830 | MIS Cortical Screw 5.0 x 45mm, Cannulated, Self-starting |
| B6785207820 | MIS Cortical Screw 5.0 x 40mm, Cannulated, Self-starting |
| B6785207810 | MIS Cortical Screw 5.0 x 35mm, Cannulated, Self-starting |
| B6785207800 | MIS Cortical Screw 5.0 x 30mm, Cannulated, Self-starting |
| B6785207790 | MIS Cortical Screw 4.5 x 50mm, Cannulated, Self-starting |
| B6785207780 | MIS Cortical Screw 4.5 x 45mm, Cannulated, Self-starting |
| B6785207770 | MIS Cortical Screw 4.5 x 40mm, Cannulated, Self-starting |
| B6785207760 | MIS Cortical Screw 4.5 x 35mm, Cannulated, Self-starting |
| B6785207750 | MIS Cortical Screw 4.5 x 30mm, Cannulated, Self-starting |
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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