Elite Expandable Interbody Fusion System 100-1054

GUDID M7401001054

Elite Inserter Fork

SPINEOLOGY INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: M7401001054
• NIH Device Record Key: c16c78d3-3c5c-41bd-a9e7-b02acb0137cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Expandable Interbody Fusion System
• Version Model Number: 101-80-01
• Catalog Number: 100-1054
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: +1(651)256-8500
• Email: info@spineology.com

Device Dimensions

• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7401001054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162879

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[M7401001054]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-18
• Device Publish Date: 2020-02-10

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
• M7401001369: CEI 595 Shaver, 15mm
• M7401001368: CEI 595 Shaver, 14mm
• M7401001367: CEI 595 Shaver, 13mm
• M7401001366: CEI 595 Shaver, 12mm
• M7401001365: CEI 595 Shaver, 11mm
• M7401001364: CEI 595 Shaver, 10mm
• M7401001363: CEI 595 Shaver, 9mm
• M7401001362: CEI 595 Shaver, 8mm
• M7401001361: CEI 595 Shaver, 7mm
• M7401001360: CEI 595 Shaver, 6mm