Inertia® Pedicle Screw and Deformity Correxxion® System

GUDID 00889929042557

Double Prebent Rod, Ø5.5 x 35mm

NEXXT SPINE, LLC

Bone-screw internal spinal fixation system rod

• Primary Device ID: 00889929042557
• NIH Device Record Key: 9649c18d-50e0-46c1-ab2e-1c96fbd0b61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inertia® Pedicle Screw and Deformity Correxxion® System
• Version Model Number: 10-38-5535
• 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: 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

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929042557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153453

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

[00889929042557]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-02
• Device Publish Date: 2020-11-18

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

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• 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