Elite Expandable Interbody Fusion System 301-0095

GUDID M7403010095

9mm Paddle Distractor

SPINEOLOGY INC.

Spinal intraoperative positioning pin, reusable

• Primary Device ID: M7403010095
• NIH Device Record Key: eb3f5b89-b3dc-42b8-82cd-985795dbe74f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Expandable Interbody Fusion System
• Version Model Number: 35-04-04-2
• Catalog Number: 301-0095
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7403010095 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

[M7403010095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-28
• Device Publish Date: 2023-12-20

On-Brand Devices [Elite Expandable Interbody Fusion System]

• M7401001054: Elite Inserter Fork
• M7401001249: Asm, 10 mm Fork
• M7405409401: Torque-Limit Handle
• M7405408951: Elite Release Tool
• M7403010176: 7mm Paddle Distractor
• M7403010095: 9mm Paddle Distractor
• M7403010094: 8mm Paddle Distractor
• M7403010031: 16mm Paddle Distractor
• M7403010030: 15mm Paddle Distractor
• M7403010029: 14mm Paddle Distractor
• M7403010028: 13mm Paddle Distractor
• M7403010027: 12mm Paddle Distractor
• M7403010026: 11mm Paddle Distractor
• M7403010025: 10mm Paddle Distractor
• M7403010022: T-Handle
• M7403010013: Mallet
• M7402800051: Slap Hammer