Inertia® MIS Pedicle Screw System
GUDID 00889929021354
MIS, Pedicle Screw, Ø5.5x30 mm
NEXXT SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00889929021354 |
| NIH Device Record Key | 45d10e28-80b0-41a7-a0ff-86ca663a5203 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inertia® MIS Pedicle Screw System |
| Version Model Number | 10-64-5530 |
| Company DUNS | 003489810 |
| Company Name | NEXXT SPINE, LLC |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com | |
| Phone | 317-436-7801 |
| Support@nexxtspine.com |
Device Dimensions
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 30 Millimeter |
| Outer Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929021354 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132412
FDA Product Code
| MNH | Orthosis, Spondylolisthesis Spinal Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
[00889929021354]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-08-02 |
| Device Publish Date | 2017-08-18 |
On-Brand Devices [Inertia® MIS Pedicle Screw System]
| 00889929019016 | Screw Loading Guide |
| 00889929019009 | Reducer |
| 00889929018804 | Tower Reattachment Guide |
| 00889929018798 | Tower Attachment Tool |
| 00889929018729 | Percutaneous Tower |
| 00889929018705 | Counter Torque Wrench |
| 00889929018682 | Dilator 2, Radel |
| 00889929019221 | Inertia MIS Reduction Tower Case |
| 00889929019214 | Inertia MIS Compressor/Distractor Case |
| 00889929019207 | Inertia MIS Percutaneous Tower Case |
| 00889929019191 | K-Wire Caddy, Long |
| 00889929019184 | Inertia MIS Rod Manipulation Case |
| 00889929019177 | Inertia MIS Screw Insertion Case |
| 00889929019160 | K-Wire Caddy |
| 00889929019153 | Inertia MIS Rod Manipulation Case |
| 00889929019146 | Inertia MIS Screw Insertion Case |
| 00889929052037 | K-Wire, Nitinol, Blunt Tip, Ø1.4x480mm |
| 00889929052020 | K-Wire, Nitinol, Trocar Tip, Ø1.4x480mm |
| 00889929053799 | K-Wire, Nitinol, Blunt Tip, Ø1.4x590mm |
| 00889929021750 | MIS, Pedicle Screw, Ø7.5x90 mm |
| 00889929021743 | MIS, Pedicle Screw, Ø7.5x85 mm |
| 00889929021736 | MIS, Pedicle Screw, Ø7.5x80 mm |
| 00889929021729 | MIS, Pedicle Screw, Ø7.5x75 mm |
| 00889929021712 | MIS, Pedicle Screw, Ø7.5x70 mm |
| 00889929021705 | MIS, Pedicle Screw, Ø7.5x65 mm |
| 00889929021699 | MIS, Pedicle Screw, Ø7.5x60 mm |
| 00889929021682 | MIS, Pedicle Screw, Ø7.5x55 mm |
| 00889929021675 | MIS, Pedicle Screw, Ø7.5x50 mm |
| 00889929021668 | MIS, Pedicle Screw, Ø7.5x45 mm |
| 00889929021651 | MIS, Pedicle Screw, Ø7.5x40 mm |
| 00889929021644 | MIS, Pedicle Screw, Ø7.5x35 mm |
| 00889929021637 | MIS, Pedicle Screw, Ø7.5x30 mm |
| 00889929021620 | MIS, Pedicle Screw, Ø7.5x25 mm |
| 00889929021613 | MIS, Pedicle Screw, Ø7.0x80 mm |
| 00889929021606 | MIS, Pedicle Screw, Ø7.0x75 mm |
| 00889929021590 | MIS, Pedicle Screw, Ø7.0x70 mm |
| 00889929021583 | MIS, Pedicle Screw, Ø7.0x65 mm |
| 00889929021576 | MIS, Pedicle Screw, Ø7.0x60 mm |
| 00889929021569 | MIS, Pedicle Screw, Ø7.0x55 mm |
| 00889929021552 | MIS, Pedicle Screw, Ø7.0x50 mm |
| 00889929021545 | MIS, Pedicle Screw, Ø7.0x45 mm |
| 00889929021538 | MIS, Pedicle Screw, Ø7.0x40 mm |
| 00889929021521 | MIS, Pedicle Screw, Ø7.0x35 mm |
| 00889929021514 | MIS, Pedicle Screw, Ø7.0x30 mm |
| 00889929021507 | MIS, Pedicle Screw, Ø7.0x25 mm |
| 00889929021491 | MIS, Pedicle Screw, Ø6.5x60 mm |
| 00889929021484 | MIS, Pedicle Screw, Ø6.5x55 mm |
| 00889929021477 | MIS, Pedicle Screw, Ø6.5x50 mm |
| 00889929021460 | MIS, Pedicle Screw, Ø6.5x45 mm |
| 00889929021453 | MIS, Pedicle Screw, Ø6.5x40 mm |
Trademark Results [Inertia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INERTIA 98774882 not registered Live/Pending |
Ogio International, Inc. 2024-09-27 |
 INERTIA 98666865 not registered Live/Pending |
Inertia, LLC 2024-07-25 |
 INERTIA 97640508 not registered Live/Pending |
Inertia Inc. 2022-10-20 |
 INERTIA 97263823 not registered Live/Pending |
AETERNA POST PRODUCTION, INC. 2022-02-11 |
 INERTIA 90251251 not registered Live/Pending |
The Carlstar Group LLC 2020-10-13 |
 INERTIA 90109735 not registered Live/Pending |
Inertia LLC 2020-08-12 |
 INERTIA 88668380 not registered Live/Pending |
Elite Tackle Group, LLC 2019-10-25 |
 INERTIA 88291597 not registered Live/Pending |
Dick's Sporting Goods, Inc. 2019-02-06 |
 INERTIA 87764186 not registered Dead/Abandoned |
Elite Tackle Group LLC 2018-01-22 |
 INERTIA 87374452 not registered Dead/Abandoned |
Bushnell Inc. 2017-03-16 |
 INERTIA 86501465 not registered Dead/Abandoned |
Buck Knives, Inc. 2015-01-12 |
 INERTIA 86446381 4882832 Live/Registered |
Michael Zubi 2014-11-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.