StaXx® XDL System 11-1450

GUDID 10840642100921

Cartridge Bi-Convex Lordotic Expandable Implant 37x16x8mm 6deg

Spine Wave, Inc.

Vertebral body prosthesis

• Primary Device ID: 10840642100921
• NIH Device Record Key: 34d7a8ff-aa61-4b58-888b-87fae490859a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StaXx® XDL System
• Version Model Number: 11-1450
• Catalog Number: 11-1450
• 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: 37 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642100921 [Primary]

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

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: 2015-10-24

On-Brand Devices [StaXx® XDL System]

• 10840642101010: Cartridge Bi-Convex Expandable Implant 37x14x8mm
• 10840642100983: Cartridge Bi-Convex Expandable Implant 37x16x8mm
• 10840642100952: Cartridge Bi-Convex Lordotic Expandable Implant 37x14x8mm 6deg
• 10840642100921: Cartridge Bi-Convex Lordotic Expandable Implant 37x16x8mm 6deg