StaXx® XD System 11-1625

GUDID 10840642100754

Cartridge Convex Expandable Implant 25x9x15mm

Spine Wave, Inc.

Vertebral body prosthesis

• Primary Device ID: 10840642100754
• NIH Device Record Key: 0be50b45-e464-4ed2-b7be-db10a5bc1507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StaXx® XD System
• Version Model Number: 11-1625
• Catalog Number: 11-1625
• 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: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642100754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101288

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

On-Brand Devices [StaXx® XD System]

• 10840642107760: StaXx® Surgical Gun
• 10840642107753: StaXx® Surgical Gun 2X
• 10840642100877: Cartridge Lordotic Expandable Implant 25x9x8mm 15deg
• 10840642100860: Cartridge Lordotic Expandable Implant 22x9x8mm 15deg
• 10840642100754: Cartridge Convex Expandable Implant 25x9x15mm
• 10840642100747: Cartridge Convex Expandable Implant 22x9x15mm
• 10840642100693: Cartridge Lordotic Expandable Implant 25x9x7mm 8deg
• 10840642100686: Cartridge Lordotic Expandable Implant 22x9x7mm 8deg
• 10840642100679: Cartridge Convex Expandable Implant 29x9x7mm
• 10840642100662: Cartridge Convex Expandable Implant 25x9x7mm
• 10840642100655: Cartridge Convex Expandable Implant 22x9x7mm
• 10840642100600: Cartridge Convex Expandable Implant 26x9x7mm
• 10840642100594: Cartridge Convex Expandable Implant 24x9x7mm
• 10840642100570: Cartridge Convex Expandable Implant Wide 25x11x21mm
• 10840642100563: Cartridge Convex Expandable Implant Wide 22x11x21mm
• 10840642100525: Cartridge Convex Expandable Implant Wide 29x11x7mm
• 10840642100518: Cartridge Convex Expandable Implant Wide 25x11x7mm
• 10840642100259: Cartridge Convex Expandable Implant Ti 25x9x7mm
• 10840642100228: Cartridge Convex Expandable Implant Ti 22x9x7mm
• 10840642100198: Cartridge Lordotic Expandable Implant Ti 25x9x7mm 8deg
• 10840642100167: Cartridge Lordotic Expandable Implant Ti 22x9x7mm 8deg
• 10840642100136: Cartridge Lordotic Expandable Implant Ti 25x9x8mm 15deg
• 10840642100105: Cartridge Lordotic Expandable Implant Ti 22x9x8mm 15deg