Inertia® Pedicle Screw System
GUDID 00889929004357
MIS Pedicle Screw, Ø5.5mm x 45mm
NEXXT SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00889929004357 |
| NIH Device Record Key | 81cb6035-28f9-4171-b3fa-bfe89a9a57f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inertia® Pedicle Screw System |
| Version Model Number | 10-14-5545 |
| 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
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929004357 [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 |
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
Moist Heat or Steam Sterilization
[00889929004357]
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 | 2015-08-28 |
On-Brand Devices [Inertia® Pedicle Screw System]
| 00889929034033 | 6mm Rod Bender, Right |
| 00889929034026 | 6mm Rod Bender, Left |
| 00889929036259 | Quarter Square Adapter, Assembly, Tri-Flat |
| 00889929036310 | Axial Hudson Handle |
| 00889929041499 | AO Axial Handle, Torque Limiting, 15 in-lb |
| 00889929041482 | Hudson Axial Handle, Ratcheting |
| 00889929041475 | Hudson T-Handle, Ratcheting |
| 00889929041741 | AO to AO Torque Limiting Adapter (15 in-lb) |
| 00889929041758 | Reduction Tab Removal Tool |
| 00889929042496 | Handle, Hudson, Axial, Fixed |
| 00889929042953 | Hybrid Rod Cutter, Table Plate |
| 00889929042946 | Hybrid Rod Cutter, Handle Extension |
| 00889929042939 | Hybrid Rod Cutter, Handle |
| 00889929042922 | Hybrid Rod Cutter |
| 00889929018620 | Inertia Screw Caddy, 65-80 |
| 00889929018613 | Inertia Screw Caddy, 85-100 |
| 00889929018606 | Inertia Reduction Screw Caddy, Long |
| 00889929018590 | Inertia Screw Caddy, Large |
| 00889929018583 | Inertia Screw Caddy, Small |
| 00889929018576 | Inertia Rod to Rod Connector Caddy |
| 00889929018569 | Inertia Rod Manipulation Case |
| 00889929018552 | Inertia Reduction Case |
| 00889929018545 | Inertia Set Screw Caddy, Revision |
| 00889929018538 | Inertia Screw Caddy, Revision, Short |
| 00889929018521 | Inertia Revision Case |
| 00889929018514 | Inertia Screw Caddy, Reduction, Short |
| 00889929018507 | Inertia Set Screw Caddy |
| 00889929018491 | Inertia Screw Caddy, Large |
| 00889929018484 | Inertia Screw Caddy, Small |
| 00889929018477 | Inertia Rod Manipulation Case |
| 00889929018460 | Inertia Screw Insertion Case |
| 00889929050484 | General Removal Case |
| 00889929052082 | Rod Bender |
| 00889929053607 | MIS Pedicle Screw, Ø6.5mm x 60mm |
| 00889929053768 | Iliac Bolt Caddy |
| 00889929017838 | In-Situ Driver, T15 |
| 00889929024898 | Straight Rod, Ø5.5mm x 300mm |
| 00889929022993 | MIS Rod, Curved, Ø5.5mm x 145mm |
| 00889929022986 | MIS Rod, Curved, Ø5.5mm x 135mm |
| 00889929022979 | MIS Rod, Curved, Ø5.5mm x 125mm |
| 00889929022962 | MIS Rod, Curved, Ø5.5mm x 115mm |
| 00889929022955 | MIS Rod, Curved, Ø5.5mm x 105mm |
| 00889929022115 | MAC Pedicle Screw, Ø4.5x25mm |
| 00889929021996 | Polyaxial Pedicle Screw, Ø7.5mm x 100mm |
| 00889929021989 | Polyaxial Pedicle Screw, Ø7.5mm x 95mm |
| 00889929021972 | Polyaxial Pedicle Screw, Ø7.5mm x 25mm |
| 00889929021965 | Polyaxial Pedicle Screw, Ø7.5mm x 20mm |
| 00889929021958 | Polyaxial Pedicle Screw, Ø7.0mm x 100mm |
| 00889929021941 | Polyaxial Pedicle Screw, Ø7.0mm x 95mm |
| 00889929021934 | Polyaxial Pedicle Screw, Ø7.0mm x 90mm |
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 |
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