Inertia® Pedicle Screw and Deformity Correxxion® System

GUDID 00889929048511

EXT Pedicle Screw, Ø5.5 x 35

NEXXT SPINE, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00889929048511
NIH Device Record Key42fcb3a2-d1c8-4bd2-825f-17cb4f4ac4a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameInertia® Pedicle Screw and Deformity Correxxion® System
Version Model Number10-68-5535
Company DUNS003489810
Company NameNEXXT SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com
Phone317-436-7801
EmailSupport@nexxtspine.com

Device Dimensions

Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter
Outer Diameter5.5 Millimeter
Length35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889929048511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889929048511]

Moist Heat or Steam Sterilization


[00889929048511]

Moist Heat or Steam Sterilization


[00889929048511]

Moist Heat or Steam Sterilization


[00889929048511]

Moist Heat or Steam Sterilization


[00889929048511]

Moist Heat or Steam Sterilization


[00889929048511]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-27
Device Publish Date2022-05-19

On-Brand Devices [Inertia® Pedicle Screw and Deformity Correxxion® System]

00889929033104MAC Pedicle Screw, Ø9.5x100 mm
00889929033098MAC Pedicle Screw, Ø9.5x65 mm
00889929033951Rod Template, 400mm
00889929039984Cort/Canc Screw, Ø6.0x55 mm
00889929039977Cort/Canc Screw, Ø6.0x50 mm
00889929039960Cort/Canc Screw, Ø6.0x45 mm
00889929039953Cort/Canc Screw, Ø6.0x40 mm
00889929039946Cort/Canc Screw, Ø6.0x35 mm
00889929039939Cort/Canc Screw, Ø6.0x30 mm
00889929042847Inertia Double Pre-Bent Rod Caddy
00889929044001EXT Reduction Pedicle Screw, Ø7.5 x 45
00889929043998EXT Reduction Pedicle Screw, Ø7.5 x 40
00889929043981EXT Reduction Pedicle Screw, Ø7.5 x 35
00889929043974EXT Reduction Pedicle Screw, Ø7.5 x 30
00889929043967EXT Reduction Pedicle Screw, Ø6.5 x 35
00889929043950EXT Reduction Pedicle Screw, Ø6.5 x 30
00889929043943EXT Reduction Pedicle Screw, Ø5.5 x 35
00889929043936EXT Reduction Pedicle Screw, Ø5.5 x 30
00889929044155EXT Reduction Pedicle Screw, Ø8.5 x 60
00889929044148EXT Reduction Pedicle Screw, Ø8.5 x 55
00889929044131EXT Reduction Pedicle Screw, Ø8.5 x 50
00889929044124EXT Reduction Pedicle Screw, Ø8.5 x 45
00889929044117EXT Reduction Pedicle Screw, Ø8.5 x 40
00889929044100EXT Pedicle Screw, Ø8.5 x 60
00889929044094EXT Pedicle Screw, Ø8.5 x 55
00889929044087EXT Pedicle Screw, Ø8.5 x 50
00889929044070EXT Pedicle Screw, Ø8.5 x 45
00889929044063EXT Pedicle Screw, Ø8.5 x 40
00889929044162EXT Reduction Pedicle Screw, Ø7.5 x 50
00889929044544Hybrid Rod Cutter Case
008899290268308.5-9.0mm/9.5-10.5mm, Implant & Instrument Case
00889929026823Set Screw Caddy, 95105
00889929026816Screw Caddy, 10.5mm
00889929026809Screw Caddy, 9.5mm
00889929026663Screw Caddy 95105
00889929026175General Case, Small
00889929021248Caddy, CORTI-FIXX™ Screws, Large
00889929020975Deformity Correxxion Case
00889929020845R2R Connector Caddy
00889929011454Inertia Corti-Fixx Screw Caddy
00889929011447Rod to Rod Caddy
00889929011430Inertia Offset Connector Caddy
00889929011423Inertia Crosslynxx Caddy
00889929011416Inertia Hook Caddy
00889929011409Deformity Correxxion Case
00889929047057Modular Dovetail Handle
00889929048528EXT Pedicle Screw, Ø6.5 x 35
00889929048511EXT Pedicle Screw, Ø5.5 x 35
00889929048504EXT Pedicle Screw, Ø4.5 x 45
00889929048498EXT Pedicle Screw, Ø4.5 x 40

Trademark Results [Inertia]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INERTIA
INERTIA
97640508 not registered Live/Pending
Inertia Inc.
2022-10-20
INERTIA
INERTIA
97263823 not registered Live/Pending
AETERNA POST PRODUCTION, INC.
2022-02-11
INERTIA
INERTIA
90251251 not registered Live/Pending
The Carlstar Group LLC
2020-10-13
INERTIA
INERTIA
90109735 not registered Live/Pending
Inertia LLC
2020-08-12
INERTIA
INERTIA
88668380 not registered Live/Pending
Elite Tackle Group, LLC
2019-10-25
INERTIA
INERTIA
88291597 not registered Live/Pending
Dick's Sporting Goods, Inc.
2019-02-06
INERTIA
INERTIA
87764186 not registered Dead/Abandoned
Elite Tackle Group LLC
2018-01-22
INERTIA
INERTIA
87374452 not registered Dead/Abandoned
Bushnell Inc.
2017-03-16
INERTIA
INERTIA
86501465 not registered Dead/Abandoned
Buck Knives, Inc.
2015-01-12
INERTIA
INERTIA
86446381 4882832 Live/Registered
Michael Zubi
2014-11-06
INERTIA
INERTIA
86445762 not registered Dead/Abandoned
FREE COUNTRY, LTD
2014-11-05
INERTIA
INERTIA
86322579 4688188 Live/Registered
Wineman Technology Inc.
2014-06-27

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