Valeo Spacer System 91.600.4608

GUDID M555916004608

Valeo II 6° 8mm Dual Cervical Trial

AMEDICA CORPORATION

Internal spinal fixation procedure kit, single-use

• Primary Device ID: M555916004608
• NIH Device Record Key: 13cf7541-cba8-4c3d-915c-00e005509d5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valeo Spacer System
• Version Model Number: A
• Catalog Number: 91.600.4608
• 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 Dimensions

• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M555916004608 [Primary]

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[M555916004608]

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 Spacer System]

• M555916006713: Valeo II C, 16x14 6° 13-14mm -0.5 Stop
• M555916006711: Valeo II C, 16x14 6° 11-12mm -0.5 Stop
• M555916006709: Valeo II C, 16x14 6° 9-10mm -0.5 Stop
• M555916006707: Valeo II C, 16x14 6° 7-8mm -0.5 Stop
• M555916006705: Valeo II C, 16x14 6° 5-6mm -0.5 Stop
• M555916006613: Valeo II C, 14x12 6° 13-14mm -0.5 Stop
• M555916006611: Valeo II C, 14x12 6° 11-12mm -0.5 Stop
• M555916006609: Valeo II C, 14x12 6° 9-10mm -0.5 Stop
• M555916006607: Valeo II C, 14x12 6° 7-8mm -0.5 Stop
• M555916006605: Valeo II C, 14x12 6° 5-6mm -0.5 Stop
• M555916006213: Valeo II C, 16x14 0° 13-14mm -0.5 Stop
• M555916006211: Valeo II C, 16x14 0° 11-12mm -0.5 Stop
• M555916006209: Valeo II C, 16x14 0° 9-10mm -0.5 Stop
• M555916006207: Valeo II C, 16x14 0° 7-8mm -0.5 Stop
• M555916006205: Valeo II C, 16x14 0° 5-6mm -0.5 Stop
• M555916006113: Valeo II C, 14x12 0° 13-14mm -0.5 Stop
• M555916006111: Valeo II C, 14x12 0° 11-12mm -0.5 Stop
• M555916006109: Valeo II C, 14x12 0° 9-10mm -0.5 Stop
• M555916006107: Valeo II C, 14x12 0° 7-8mm -0.5 Stop
• M555916006105: Valeo II C, 14x12 0° 5-6mm -0.5 Stop
• M555916005014: Valeo II Dual Convex Cervical Trial, 14mm
• M555916005013: Valeo II Dual Convex Cervical Trial, 13mm
• M555916005012: Valeo II Dual Convex Cervical Trial, 12mm
• M555916005011: Valeo II Dual Convex Cervical Trial, 11mm
• M555916005010: Valeo II Dual Convex Cervical Trial, 10mm
• M555916005009: Valeo II Dual Convex Cervical Trial, 9mm
• M555916005008: Valeo II Dual Convex Cervical Trial, 8mm
• M555916005007: Valeo II Dual Convex Cervical Trial, 7mm
• M555916005006: Valeo II Dual Convex Cervical Trial, 6mm
• M555916004614: Valeo II 6° 14mm Dual Cervical Trial
• M555916004613: Valeo II 6° 13mm Dual Cervical Trial
• M555916004612: Valeo II 6° 12mm Dual Cervical Trial
• M555916004611: Valeo II 6° 11mm Dual Cervical Trial
• M555916004610: Valeo II 6° 10mm Dual Cervical Trial
• M555916004609: Valeo II 6° 9mm Dual Cervical Trial
• M555916004608: Valeo II 6° 8mm Dual Cervical Trial
• M555916004607: Valeo II 6° 7mm Dual Cervical Trial
• M555916004606: Valeo II 6° 6mm Dual Cervical Trial
• M555916004605: Valeo II 6° 5mm Dual Cervical Trial
• M555916004014: Valeo II 0° 14mm Dual Cervical Trial
• M555916004013: Valeo II 0° 13mm Dual Cervical Trial
• M555916004012: Valeo II 0° 12mm Dual Cervical Trial
• M555916004011: Valeo II 0° 11mm Dual Cervical Trial
• M555916004010: Valeo II 0° 10mm Dual Cervical Trial
• M555916004009: Valeo II 0° 9mm Dual Cervical Trial
• M555916004008: Valeo II 0° 8mm Dual Cervical Trial
• M555916004007: Valeo II 0° 7mm Dual Cervical Trial
• M555916004006: Valeo II 0° 6mm Dual Cervical Trial
• M555916004005: Valeo II 0° 5mm Dual Cervical Trial
• M555916003014: Valeo II Convex 14mm Dual Cervical Trial