Valeo Interbody Fusion System 11.016.5123

GUDID M555110165123

Valeo II AL, 36x28, 12°, 13mm

AMEDICA CORPORATION

Vertebral body prosthesis

• Primary Device ID: M555110165123
• NIH Device Record Key: deb5f046-a5a8-4d8f-81ca-df9116e25b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valeo Interbody Fusion System
• Version Model Number: F
• Catalog Number: 11.016.5123
• 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: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M555110165123 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M555110165123]

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: 2017-12-29

On-Brand Devices [Valeo Interbody Fusion System]

• M555910133309: PL Trial 9X25, 0 Degree, Integral Shaft, 9mm
• M555910023108: Trial 16x12, 0°, 8mm
• M555123011513: Valeo II PL 11x23 5°, 13mm
• M555110165123: Valeo II AL, 36x28, 12°, 13mm
• M555110091005: Valeo C 16x12, 0°, 5mm with Alternate Texturing