Inertia® Pedicle Screw and Deformity Correxxion® System
GUDID 00889929007280
MAC Pedicle Screw, Ø8.5x65mm
NEXXT SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 00889929007280 |
| NIH Device Record Key | 84f2f877-556c-475d-b47b-159fae3ec2ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inertia® Pedicle Screw and Deformity Correxxion® System |
| Version Model Number | 10-22-8565 |
| 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 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
| Device Size Text, specify | 0 |
| Length | 65 Millimeter |
| Outer Diameter | 8.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889929007280 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153453
FDA Product Code
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
Moist Heat or Steam Sterilization
[00889929007280]
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 | 2016-07-06 |
On-Brand Devices [Inertia® Pedicle Screw and Deformity Correxxion® System]
| 00889929033104 | MAC Pedicle Screw, Ø9.5x100 mm |
| 00889929033098 | MAC Pedicle Screw, Ø9.5x65 mm |
| 00889929033951 | Rod Template, 400mm |
| 00889929039984 | Cort/Canc Screw, Ø6.0x55 mm |
| 00889929039977 | Cort/Canc Screw, Ø6.0x50 mm |
| 00889929039960 | Cort/Canc Screw, Ø6.0x45 mm |
| 00889929039953 | Cort/Canc Screw, Ø6.0x40 mm |
| 00889929039946 | Cort/Canc Screw, Ø6.0x35 mm |
| 00889929039939 | Cort/Canc Screw, Ø6.0x30 mm |
| 00889929042847 | Inertia Double Pre-Bent Rod Caddy |
| 00889929044001 | EXT Reduction Pedicle Screw, Ø7.5 x 45 |
| 00889929043998 | EXT Reduction Pedicle Screw, Ø7.5 x 40 |
| 00889929043981 | EXT Reduction Pedicle Screw, Ø7.5 x 35 |
| 00889929043974 | EXT Reduction Pedicle Screw, Ø7.5 x 30 |
| 00889929043967 | EXT Reduction Pedicle Screw, Ø6.5 x 35 |
| 00889929043950 | EXT Reduction Pedicle Screw, Ø6.5 x 30 |
| 00889929043943 | EXT Reduction Pedicle Screw, Ø5.5 x 35 |
| 00889929043936 | EXT Reduction Pedicle Screw, Ø5.5 x 30 |
| 00889929044155 | EXT Reduction Pedicle Screw, Ø8.5 x 60 |
| 00889929044148 | EXT Reduction Pedicle Screw, Ø8.5 x 55 |
| 00889929044131 | EXT Reduction Pedicle Screw, Ø8.5 x 50 |
| 00889929044124 | EXT Reduction Pedicle Screw, Ø8.5 x 45 |
| 00889929044117 | EXT Reduction Pedicle Screw, Ø8.5 x 40 |
| 00889929044100 | EXT Pedicle Screw, Ø8.5 x 60 |
| 00889929044094 | EXT Pedicle Screw, Ø8.5 x 55 |
| 00889929044087 | EXT Pedicle Screw, Ø8.5 x 50 |
| 00889929044070 | EXT Pedicle Screw, Ø8.5 x 45 |
| 00889929044063 | EXT Pedicle Screw, Ø8.5 x 40 |
| 00889929044162 | EXT Reduction Pedicle Screw, Ø7.5 x 50 |
| 00889929044544 | Hybrid Rod Cutter Case |
| 00889929026830 | 8.5-9.0mm/9.5-10.5mm, Implant & Instrument Case |
| 00889929026823 | Set Screw Caddy, 95105 |
| 00889929026816 | Screw Caddy, 10.5mm |
| 00889929026809 | Screw Caddy, 9.5mm |
| 00889929026663 | Screw Caddy 95105 |
| 00889929026175 | General Case, Small |
| 00889929021248 | Caddy, CORTI-FIXX™ Screws, Large |
| 00889929020975 | Deformity Correxxion Case |
| 00889929020845 | R2R Connector Caddy |
| 00889929011454 | Inertia Corti-Fixx Screw Caddy |
| 00889929011447 | Rod to Rod Caddy |
| 00889929011430 | Inertia Offset Connector Caddy |
| 00889929011423 | Inertia Crosslynxx Caddy |
| 00889929011416 | Inertia Hook Caddy |
| 00889929011409 | Deformity Correxxion Case |
| 00889929047057 | Modular Dovetail Handle |
| 00889929048528 | EXT Pedicle Screw, Ø6.5 x 35 |
| 00889929048511 | EXT Pedicle Screw, Ø5.5 x 35 |
| 00889929048504 | EXT Pedicle Screw, Ø4.5 x 45 |
| 00889929048498 | EXT Pedicle Screw, Ø4.5 x 40 |
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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