V3” Segmental Plating System 1121-05-0008

GUDID M68111210500080

8mm Four Hole Plate Assembly, V3™ Segmental Plating System

ATLAS SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: M68111210500080
• NIH Device Record Key: 8306ba7e-8825-4790-93fb-fc8ac3e831b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V3” Segmental Plating System
• Version Model Number: 1121-05-0008
• Catalog Number: 1121-05-0008
• Company DUNS: 140801007
• Company Name: ATLAS SPINE, INC.
• 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: true
• 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

Device Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68111210500080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182418

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

[M68111210500080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-26
• Device Publish Date: 2024-08-16

On-Brand Devices [V3” Segmental Plating System]

• M68111210500200: 20mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500190: 19mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500180: 18mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500170: 17mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500160: 16mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500150: 15mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500140: 14mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500130: 13mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500120: 12mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500110: 11mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500100: 10mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500090: 9mm Four Hole Plate Assembly, V3™ Segmental Plating System
• M68111210500080: 8mm Four Hole Plate Assembly, V3™ Segmental Plating System