Inertia® Pedicle Screw System

GUDID 00889929034033

6mm Rod Bender, Right

NEXXT SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00889929034033
• NIH Device Record Key: 2e331e57-3469-4b98-929e-f405c11f28c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inertia® Pedicle Screw System
• Version Model Number: I10-30-13R
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929034033 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00889929034033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-28
• Device Publish Date: 2019-10-18

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