Leva™ Spacer System 11-7308

GUDID 10840642100389

Fixed Implant 22mm x 10mm x 8mm

Spine Wave, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 10840642100389
• NIH Device Record Key: 8ba1c1fd-e05d-4eab-827f-ef9b001b2951
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leva™ Spacer System
• Version Model Number: 11-7308
• Catalog Number: 11-7308
• 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

• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642100389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151581

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: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-10-24

On-Brand Devices [Leva™ Spacer System]

• 10840642100495: Expandable Implant 22mm x 10mm x 14mm
• 10840642100488: Expandable Implant 22mm x 10mm x 13mm
• 10840642100471: Expandable Implant 22mm x 10mm x 12mm
• 10840642100464: Expandable Implant 22mm x 10mm x 11mm
• 10840642100457: Expandable Implant 22mm x 10mm x 10mm
• 10840642100440: Fixed Implant 22mm x 10mm x 14mm
• 10840642100433: Fixed Implant 22mm x 10mm x 13mm
• 10840642100426: Fixed Implant 22mm x 10mm x 12mm
• 10840642100419: Fixed Implant 22mm x 10mm x 11mm
• 10840642100402: Fixed Implant 22mm x 10mm x 10mm
• 10840642100396: Fixed Implant 22mm x 10mm x 9mm
• 10840642100389: Fixed Implant 22mm x 10mm x 8mm
• 10840642100372: Fixed Implant 22mm x 10mm x 7mm
• 10840642100358: Fixed Implant 25mm x 10mm x 14mm
• 10840642100341: Fixed Implant 25mm x 10mm x 13mm
• 10840642100334: Fixed Implant 25mm x 10mm x 12mm
• 10840642100327: Fixed Implant 25mm x 10mm x 11mm
• 10840642100310: Fixed Implant 25mm x 10mm x 10mm
• 10840642100099: Fixed Implant 25mm x 10mm x 9mm
• 10840642100082: Fixed Implant 25mm x 10mm x 8mm
• 10840642100075: Fixed Implant 25mm x 10mm x 7mm
• 10840642100068: Expandable Implant 25mm x 10mm x 15mm
• 10840642100051: Expandable Implant 25mm x 10mm x 14mm
• 10840642100044: Expandable Implant 25mm x 10mm x 13mm
• 10840642100037: Expandable Implant 25mm x 10mm x 12mm
• 10840642100020: Expandable Implant 25mm x 10mm x 11mm
• 10840642100013: Expandable Implant 25mm x 10mm x 10mm