Inertia® Pedicle Screw System

GUDID 00889929006566

Straight Rod, Ø5.5mm x 70mm

NEXXT SPINE, LLC

Bone-screw internal spinal fixation system rod

• Primary Device ID: 00889929006566
• NIH Device Record Key: 9e2811f9-df13-4a15-80e9-7a713253d58b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inertia® Pedicle Screw System
• Version Model Number: 10-7-5570
• 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
• 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

• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929006566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090984

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

Moist Heat or Steam Sterilization

[00889929006566]

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: 2015-09-10

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
• 00889929024898: Straight Rod, Ø5.5mm x 300mm
• 00889929022993: MIS Rod, Curved, Ø5.5mm x 145mm
• 00889929022986: MIS Rod, Curved, Ø5.5mm x 135mm
• 00889929022979: MIS Rod, Curved, Ø5.5mm x 125mm
• 00889929022962: MIS Rod, Curved, Ø5.5mm x 115mm
• 00889929022955: MIS Rod, Curved, Ø5.5mm x 105mm
• 00889929022115: MAC Pedicle Screw, Ø4.5x25mm
• 00889929021996: Polyaxial Pedicle Screw, Ø7.5mm x 100mm
• 00889929021989: Polyaxial Pedicle Screw, Ø7.5mm x 95mm
• 00889929021972: Polyaxial Pedicle Screw, Ø7.5mm x 25mm
• 00889929021965: Polyaxial Pedicle Screw, Ø7.5mm x 20mm
• 00889929021958: Polyaxial Pedicle Screw, Ø7.0mm x 100mm
• 00889929021941: Polyaxial Pedicle Screw, Ø7.0mm x 95mm
• 00889929021934: Polyaxial Pedicle Screw, Ø7.0mm x 90mm