DIAM™ Spinal Stabilization System CS001A0015

GUDID 03701521300385

COMPANION SPINE FRANCE

Lumbar decompression interspinous spacer

• Primary Device ID: 03701521300385
• NIH Device Record Key: 965b132a-2237-41ed-8400-32159adf4d0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIAM™ Spinal Stabilization System
• Version Model Number: DIAM, Spinal Stabilization System Crimps
• Catalog Number: CS001A0015
• Company DUNS: 275237939
• Company Name: COMPANION SPINE FRANCE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
GS1	03701521300385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240043

FDA Product Code

• NQO: Prosthesis, Spinous Process Spacer/Plate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [DIAM™ Spinal Stabilization System]

• 03701521300385: DIAM, Spinal Stabilization System Crimps
• 03701521300378: DIAM, Spinal Stabilization System 14 mm
• 03701521300361: DIAM, Spinal Stabilization System 12 mm
• 03701521300354: DIAM, Spinal Stabilization System 10 mm
• 03701521300347: DIAM, Spinal Stabilization System 08 mm