Velocity® Expandable Interbody System 11-2364

GUDID 10840642106855

Expandable Implant, 45(L) X 18(W) X 8-13(H) 10 Degree Lordotic

Spine Wave, Inc.

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 10840642106855
• NIH Device Record Key: 92d9b7b4-c0a7-44a6-911a-da85fd161368
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velocity® Expandable Interbody System
• Version Model Number: 11-2364
• Catalog Number: 11-2364
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• 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: false
• 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

Customer Support Contacts

• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Dimensions

• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642106855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152620

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-08-31

Devices Manufactured by Spine Wave, Inc.

• 10840642169706 - Salvo® Spine System: 2024-11-12 MIS Screw Adjuster, T25, Short
• 10840642171310 - Salvo® Spine System: 2024-11-12 XT Screwdriver, T25, 5.5/6.0 mm
• 10840642171341 - Salvo® Spine System: 2024-11-12 XT Counter Torque Wrench, Handle
• 10840642171358 - Salvo® Spine System: 2024-11-12 XT Counter Torque Wrench, Sleeve
• 10840642175226 - Salvo® Spine System: 2024-11-12 XT Counter Torque, Fork
• 10840642175233 - Salvo® Spine System: 2024-11-12 XT Expandable Locking Screw Inserter
• 10840642175240 - Salvo® Spine System: 2024-11-12 XT Final Torque Driver, T25, 5.5/6.0 mm
• 10840642175295 - Salvo® Spine System: 2024-11-12 Screwdriver, Bone Screw