Valeo Interbody Fusion System 91.002.3108

GUDID M555910023108

Trial 16x12, 0°, 8mm

AMEDICA CORPORATION

Internal spinal fixation procedure kit, single-use

• Primary Device ID: M555910023108
• NIH Device Record Key: a47a6643-5df3-47f6-a9ae-5f23e1bc2f12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valeo Interbody Fusion System
• Version Model Number: C
• Catalog Number: 91.002.3108
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com
• Phone: 801-839-3500
• Email: customerservice@amedica.com

Device Dimensions

• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter
• Length: 16 Millimeter
• Width: 12 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M555910023108 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

[M555910023108]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-06-07
• 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
• M555910096529: Valeo Corpectomy Trials, 16x12mm, 6º , 29mm
• M555910096526: Valeo Corpectomy Trials, 16x12mm, 6º , 26mm
• M555910095551: 16x12mm Ti Corpectomy Fork
• M555910070003: Case 1 Tray 1 Valeo PS