Patriot Spinal Fixation System

GUDID 00811771031793

Patriot Reduction Screw, 8.0 x 100mm

VALORUS SPINE LLC

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00811771031793
• NIH Device Record Key: 399aff36-523b-4f04-8ef0-39f71a04c7d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patriot Spinal Fixation System
• Version Model Number: 10-02-8100
• Company DUNS: 080841846
• Company Name: VALORUS 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: false
• 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: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com
• Phone: 7607994353
• Email: lfero@valorusspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811771031793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180324

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

[00811771031793]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Patriot Spinal Fixation System]

• 00811771033131: Precontoured Rod, 120mm
• 00811771033124: Precontoured Rod, 110mm
• 00811771033117: Precontoured Rod, 95mm
• 00811771033100: Precontoured Rod, 85mm
• 00811771033094: Precontoured Rod, 75mm
• 00811771033087: Precontoured Rod, 65mm
• 00811771033070: Precontoured Rod, 55mm
• 00811771033063: Precontoured Rod, 45mm
• 00811771033056: Precontoured Rod, 35mm
• 00811771033049: Straight Rod, 95mm
• 00811771033032: Straight Rod, 85mm
• 00811771033025: Straight Rod, 75mm
• 00811771033018: Straight Rod, 65mm
• 00811771033001: Straight Rod, 55mm
• 00811771032998: Straight Rod, 45mm
• 00811771032981: Straight Rod, 35mm
• 00811771032974: Patriot Instrument Tray #2
• 00811771032967: Patriot Instrument Tray #1
• 00811771032950: Patriot Implant Tray
• 00811771032943: Guidewire, NiTi
• 00811771032936: Reduction Screwdriver
• 00811771032929: High Top Screw Tab Breaker
• 00811771032912: Rod Pusher
• 00811771032905: Rod Gripper
• 00811771032899: Crosslink Driver
• 00811771032882: Crosslink Torque Handle
• 00811771032875: Crosslink Caliper
• 00811771032868: Crosslink Inserter
• 00811771032851: Guidewire, SS
• 00811771032844: Ratcheting T-Handle
• 00811771032837: Ratcheting Axial Handle
• 00811771032820: Final Tightener
• 00811771032813: Final Tightening Driver
• 00811771032806: Counter-Torque
• 00811771032790: Rod Reducer
• 00811771032783: Rod Rocker
• 00811771032776: In-Situ Bender, Left
• 00811771032769: In-Situ Bender, Right
• 00811771032752: Distractor
• 00811771032745: Compressor
• 00811771032738: Rod Holder
• 00811771032721: Rod Bender
• 00811771032714: Rod Template, 400mm
• 00811771032707: Head Adjuster
• 00811771032691: Static Driver
• 00811771032684: Screw Driver
• 00811771032677: Tap, 8.0
• 00811771032660: Tap, 7.0
• 00811771032653: Tap, 6.0
• 00811771032646: Tap, 5.0