Valeo Fusion System 91.009.9011

GUDID M555910099011

Amedica Trial Case, Case Assembly

AMEDICA CORPORATION

Internal spinal fixation procedure kit, single-use

• Primary Device ID: M555910099011
• NIH Device Record Key: 61a0119a-37a4-4b54-987c-07f9bed347a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valeo Fusion System
• Version Model Number: A
• Catalog Number: 91.009.9011
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 801-839-3500
• Email: customerservice@amedica.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M555910099011 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Sterilization

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

[M555910099011]

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 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