Inertia® CONNEXX™ Modular Pedicle Screw System

GUDID 00889929051863

Reduction Housing Inserter

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889929051863
• NIH Device Record Key: 757252c6-8055-41bf-9075-93c4f5cb193a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inertia® CONNEXX™ Modular Pedicle Screw System
• Version Model Number: I20-08-11
• 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: 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

Customer Support Contacts

• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929051863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221905

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

[00889929051863]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-25
• Device Publish Date: 2023-04-17

On-Brand Devices [Inertia® CONNEXX™ Modular Pedicle Screw System]

• 00889929051108: MIS, Ø5.5x400 Rod, Straight
• 00889929051085: MIS, Ø5.5x85 Rod, Curved
• 00889929050927: Cann Shank, Ø5.0x55mm
• 00889929050910: Cann Shank, Ø5.0x50mm
• 00889929050903: Cann Shank, Ø5.0x45mm
• 00889929050897: Cann Shank, Ø5.0x40mm
• 00889929050880: Cann Shank, Ø5.0x35mm
• 00889929050873: Cann Shank, Ø5.0x30mm
• 00889929050613: Shank, Ø7.0x40mm
• 00889929050606: Shank, Ø7.0x35mm
• 00889929050590: CC Shank, Ø7.5x55mm
• 00889929050583: CC Shank, Ø7.5x50mm
• 00889929050576: CC Shank, Ø7.5x45mm
• 00889929050569: CC Shank, Ø7.5x40mm
• 00889929050552: CC Shank, Ø7.5x35mm
• 00889929050545: CC Shank, Ø6.5x55mm
• 00889929050538: CC Shank, Ø6.5x50mm
• 00889929050521: CC Shank, Ø6.5x45mm
• 00889929050514: CC Shank, Ø6.5x40mm
• 00889929050507: CC Shank, Ø6.5x35mm
• 00889929050491: CC Shank, Ø5.5x55mm
• 00889929048825: MIS, Ø6.0x200 Rod, Straight
• 00889929048818: MIS, Ø5.5x200 Rod, Straight
• 00889929048665: MIS, Ø6.0x35 Rod, Curved
• 00889929048658: MIS, Ø5.5x110 Rod, Curved
• 00889929048641: MIS, Ø5.5x100 Rod, Curved
• 00889929048634: MIS, Ø5.5x90 Rod, Curved
• 00889929048627: MIS, Ø5.5x80 Rod, Curved
• 00889929048610: MIS, Ø5.5x75 Rod, Curved
• 00889929048603: MIS, Ø5.5x70 Rod, Curved
• 00889929048597: MIS, Ø5.5x65 Rod, Curved
• 00889929048580: MIS, Ø5.5x60 Rod, Curved
• 00889929048573: MIS, Ø5.5x55 Rod, Curved
• 00889929048566: MIS, Ø5.5x50 Rod, Curved
• 00889929048559: MIS, Ø5.5x45 Rod, Curved
• 00889929048542: MIS, Ø5.5x40 Rod, Curved
• 00889929048535: MIS, Ø5.5x35 Rod, Curved
• 00889929048405: Tulip Head
• 00889929048382: Reduction Head
• 00889929048368: Extended Tab Medium
• 00889929048078: Cann CC Shank, Ø8.5x40mm
• 00889929048061: Cann CC Shank, Ø7.5x25mm
• 00889929048054: Cann CC Shank, Ø7.0x25mm
• 00889929048047: Cann CC Shank, Ø6.5x25mm
• 00889929048030: Cann CC Shank, Ø6.0x25mm
• 00889929048023: Cann CC Shank, Ø5.5x25mm
• 00889929048016: Cann CC Shank, Ø5.0x25mm
• 00889929047927: CC Shank, Ø8.5x40mm
• 00889929047910: CC Shank, Ø5.5x50mm
• 00889929047903: CC Shank, Ø7.0x25mm