Valeo Fusion System 11.004.1610

GUDID M555110041610

Valeo PL,9x21, 6°, 10mm

AMEDICA CORPORATION

Vertebral body prosthesis

• Primary Device ID: M555110041610
• NIH Device Record Key: fcac1214-aea4-4905-82b2-42293ef79511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valeo Fusion System
• Version Model Number: B
• Catalog Number: 11.004.1610
• Company DUNS: 028629553
• Company Name: AMEDICA CORPORATION
• 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: 801-839-3500
• Email: customerservice@amedica.com

Device Dimensions

• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M555110041610 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M555110041610]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-01-01

On-Brand Devices [Valeo Fusion System]

• M555910099021: Amedica VBR Small Trial Caddy Assembly
• M555910099011: Amedica Trial Case, Case Assembly
• M555910099002: Valeo VBR Trial Caddy
• M555910095510: Valeo Corpectomy Caliper
• M555110041610: Valeo PL,9x21, 6°, 10mm
• M555110041609: Valeo PL,9x21, 6°, 9mm
• M555110041608: Valeo PL,9x21, 6°, 8mm
• M555110041607: Valeo PL,9x21, 6°, 7mm
• M555110041015: Valeo PL,9x21, 0°, 15mm