Foundation Surgical Vertiwedge OV426601415

GUDID 00810141048515

Vertiwedge 4-Hole, 26W x 60L x 14H x 15L°

FOUNDATION SURGICAL GROUP INC

Vertebral body prosthesis

• Primary Device ID: 00810141048515
• NIH Device Record Key: 1de21d08-b6dc-4ad5-ac77-87a4f689b64c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foundation Surgical Vertiwedge
• Version Model Number: OV426601415
• Catalog Number: OV426601415
• Company DUNS: 119029419
• Company Name: FOUNDATION SURGICAL GROUP 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: true
• 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: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com
• Phone: 727-209-7436
• Email: Foundationsurgical@orthoex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810141048515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241468

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-06
• Device Publish Date: 2026-02-26

On-Brand Devices [Foundation Surgical Vertiwedge]

• 00810141048010: Vertiwedge 4-Hole, 26W x 60L x 12H x 15L°
• 00810141048003: Vertiwedge 4-Hole, 26W x 55L x 12H x 15L°
• 00810141047990: Vertiwedge 4-Hole, 26W x 50L x 12H x 15L°
• 00810141047983: Vertiwedge 4-Hole, 26W x 45L x 12H x 15L°
• 00810141047976: Vertiwedge 4-Hole, 26W x 40L x 12H x 15L°
• 00810141047914: Vertiwedge 4-Hole, 26W x 60L x 12H x 10L°
• 00810141047907: Vertiwedge 4-Hole, 26W x 55L x 12H x 10L°
• 00810141047891: Vertiwedge 4-Hole, 26W x 50L x 12H x 10L°
• 00810141047884: Vertiwedge 4-Hole, 26W x 45L x 12H x 10L°
• 00810141047877: Vertiwedge 4-Hole, 26W x 40L x 12H x 10L°
• 00810141047617: Vertiwedge 4-Hole, 26W x 60L x 10H x 10L°
• 00810141047600: Vertiwedge 4-Hole, 26W x 55L x 10H x 10L°
• 00810141047594: Vertiwedge 4-Hole, 26W x 50L x 10H x 10L°
• 00810141047587: Vertiwedge 4-Hole, 26W x 45L x 10H x 10L°
• 00810141047570: Vertiwedge 4-Hole, 26W x 40L x 10H x 10L°
• 00810141047419: Vertiwedge 4-Hole, 26W x 60L x 8H x 3L°
• 00810141047402: Vertiwedge 4-Hole, 26W x 55L x 8H x 3L°
• 00810141047396: Vertiwedge 4-Hole, 26W x 50L x 8H x 3L°
• 00810141047389: Vertiwedge 4-Hole, 26W x 45L x 8H x 3L°
• 00810141047372: Vertiwedge 4-Hole, 26W x 40L x 8H x 3L°
• 00810141047259: Plate, 4-Hole
• 00810141048614: Vertiwedge 4-Hole, 26W x 60L x 14H x 20L°
• 00810141048607: Vertiwedge 4-Hole, 26W x 55L x 14H x 20L°
• 00810141048591: Vertiwedge 4-Hole, 26W x 50L x 14H x 20L°
• 00810141048584: Vertiwedge 4-Hole, 26W x 45L x 14H x 20L°
• 00810141048577: Vertiwedge 4-Hole, 26W x 40L x 14H x 20L°
• 00810141048515: Vertiwedge 4-Hole, 26W x 60L x 14H x 15L°
• 00810141048508: Vertiwedge 4-Hole, 26W x 55L x 14H x 15L°
• 00810141048492: Vertiwedge 4-Hole, 26W x 50L x 14H x 15L°
• 00810141048485: Vertiwedge 4-Hole, 26W x 45L x 14H x 15L°
• 00810141048478: Vertiwedge 4-Hole, 26W x 40L x 14H x 15L°