Rampart One Lumbar Interbody Fusion System 490-1824

GUDID M7404901824

Inserter Driver

SPINEOLOGY INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: M7404901824
• NIH Device Record Key: 5df142b5-4e6e-436f-bfe7-1a4090d1e910
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rampart One Lumbar Interbody Fusion System
• Version Model Number: 49-05-03
• Catalog Number: 490-1824
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7404901824 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

[M7404901824]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-01-09

On-Brand Devices [Rampart One Lumbar Interbody Fusion System]

• M7404902207: Rampart One Oblique Trial, 14mm, M, 8°
• M7404902206: Rampart One Oblique Trial, 12mm, M, 8°
• M7404902205: Rampart One Oblique Trial, 10.5mm, M, 8°
• M7404902203: Rampart One Oblique Trial, 14mm, S, 8°
• M7404902202: Rampart One Oblique Trial, 12mm, S, 8°
• M7404902201: Rampart One Oblique Trial, 10.5mm, S, 8°
• M7404902028: Rampart One Trial Inserter
• M7404902026: Rampart One Trial, 16mm, L, 12°
• M7404902025: Rampart One Trial, 14mm, L, 12°
• M7404902024: Rampart One Trial, 12mm, L, 12°
• M7404902022: Rampart One Trial, 16mm, L, 8°
• M7404902021: Rampart One Trial, 14mm, L, 8°
• M7404902020: Rampart One Trial, 12mm, L, 8°
• M7404902017: Rampart One Trial, 16mm, M, 12°
• M7404902016: Rampart One Trial, 14mm, M, 12°
• M7404902015: Rampart One Trial, 12mm, M, 12°
• M7404902013: Rampart One Trial, 16mm, M, 8°
• M7404902012: Rampart One Trial, 14mm, M, 8°
• M7404902011: Rampart One Trial, 12mm, M, 8°
• M7404902010: Rampart One Trial, 10.5mm, M, 8°
• M7404902007: Rampart One Trial, 14mm, S, 12°
• M7404902006: Rampart One Trial, 12mm, S, 12°
• M7404902003: Rampart One Trial, 14mm, S, 8°
• M7404902002: Rampart One Trial, 12mm, S, 8°
• M7404902001: Rampart One Trial, 10.5mm, S, 8°
• M7404900011: Rampart One Inserter
• M7404901823: Rampart One Inserter
• M7404900006: Rampart One Inserter Block
• M7404900004: Rampart One Guide, 16mm
• M7404900003: Rampart One Guide, 14mm
• M7404900002: Rampart One Guide, 12mm
• M7404900001: Rampart One Guide, 10.5mm
• M7404902033: Rampart One Trial, 18mm, M, 20°
• M7404902032: Rampart One Trial, 18mm, M, 16°
• M7404902031: Rampart One Trial, 16mm, M, 20°
• M7404902030: Rampart One Trial, 16mm, M, 16°
• M7404902029: Rampart One Trial, 14mm, M, 16°
• M7404901822: Rampart One Standard Spacer, 18mm, L, 20°
• M7404901821: Rampart One Standard Spacer, 18mm, L, 16°
• M7404901820: Rampart One Standard Spacer, 18mm, S, 16°
• M7404901819: Rampart One Standard Spacer, 18mm, S, 20°
• M7404901818: Rampart One Standard Spacer, 18mm, M, 20°
• M7404901817: Rampart One Standard Spacer, 18mm, M, 16°
• M7404901612: Rampart One Standard Spacer, 16mm, L, 20°
• M7404901611: Rampart One Standard Spacer, 16mm, L, 16°
• M7404901610: Rampart One Standard Spacer, 16mm, S, 20°
• M7404901609: Rampart One Standard Spacer, 16mm, S, 16°
• M7404901608: Rampart One Standard Spacer, 16mm, M, 20°
• M7404901607: Rampart One Standard Spacer, 16mm, M, 16°
• M7404901410: Rampart One Standard Spacer, 14mm, L, 16°