Patriot SI

GUDID M9431001750000

Posterior SI Joint Fusion Implant

Spinal Simplicity, LLC

Sacroiliac joint intra-articular arthrodesis implant

• Primary Device ID: M9431001750000
• NIH Device Record Key: 7e136e98-2742-4d1f-9021-307325187de9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patriot SI
• Version Model Number: 10-0175-000
• Company DUNS: 963359513
• Company Name: Spinal Simplicity, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9431001750000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232259

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-24
• Device Publish Date: 2024-05-06

On-Brand Devices [Patriot SI]

• M9432001940000: Guidewire, Blunt
• M9432001910000: Impactor
• M9432001900000: Drillcorticator
• M9432001890000: Joint Sleeve
• M9432001880000: Joint Finder
• M9432001860000: Guidewire, Blunt
• M9432001850000: Insertion Instrument
• M9430018700000: Guidewire, Trocar
• M9431001750000: Posterior SI Joint Fusion Implant
• M9432001990000: Luer Insertion Instrument
• M9433500070000: Single Use Instrument Kit